Trial Outcomes & Findings for Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery (NCT NCT01612351)
NCT ID: NCT01612351
Last Updated: 2026-03-17
Results Overview
Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the number of patients who have a partial or complete response to therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
11 weeks
Results posted on
2026-03-17
Participant Flow
Participant milestones
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|
|
Chemotherapy
STARTED
|
40
|
|
Chemotherapy
COMPLETED
|
40
|
|
Chemotherapy
NOT COMPLETED
|
0
|
|
Transoral Surgery
STARTED
|
39
|
|
Transoral Surgery
COMPLETED
|
39
|
|
Transoral Surgery
NOT COMPLETED
|
0
|
|
Post-Operative Treatment
STARTED
|
39
|
|
Post-Operative Treatment
COMPLETED
|
39
|
|
Post-Operative Treatment
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery
Baseline characteristics by cohort
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=40 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|
|
Age, Continuous
|
57.5 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=10 Participants
|
|
Disease Location
Supraglottic Larynx
|
5 Participants
n=10 Participants
|
|
Disease Location
Oral Cavity
|
4 Participants
n=10 Participants
|
|
Disease Location
Hypopharynx
|
1 Participants
n=10 Participants
|
|
Disease Location
Oropharynx
|
30 Participants
n=10 Participants
|
|
Stage of disease
T1N1
|
1 Participants
n=10 Participants
|
|
Stage of disease
T1N2a
|
4 Participants
n=10 Participants
|
|
Stage of disease
T1N2b
|
6 Participants
n=10 Participants
|
|
Stage of disease
T2N1
|
4 Participants
n=10 Participants
|
|
Stage of disease
T2N2a
|
5 Participants
n=10 Participants
|
|
Stage of disease
T2N2b
|
12 Participants
n=10 Participants
|
|
Stage of disease
T2N2c
|
2 Participants
n=10 Participants
|
|
Stage of disease
T3N0
|
3 Participants
n=10 Participants
|
|
Stage of disease
T3N2c
|
1 Participants
n=10 Participants
|
|
Stage of disease
T4N1
|
2 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 11 weeksEvaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the number of patients who have a partial or complete response to therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=40 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Overall Response Rate
|
37 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants started to receive study treatment.
Percentage of patients successfully completing 3 part therapy will be used to assess the feasibility of 3 part therapy consisting of induction chemotherapy, surgery, and risk-adapted use of chemoradiation.
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=40 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Feasibility of 3 Part Therapy
completed
|
39 Participants
|
—
|
—
|
|
Feasibility of 3 Part Therapy
not-completed
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: One patient withdrew before surgery.
Number of patients who no longer need radiation (have decreases in risk level post induction therapy). Estimations of Risk level pre-induction will be based on physical examination and imaging, post-induction risk level will be determined based on pathologic evaluation or surgical specimen.
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=39 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy.
|
29 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 7.25 yearsPopulation: Participants who completed study therapy
Overall survival is measured from the time the patient goes on treatment until death.
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=38 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Overall Survival
|
97 percentage
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7.25 yearsPopulation: Participants who completed therapy were analyzed for disease progression.
Progression-free survival associated with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation. Defined as per RECIST criteria. Physical examination, imaging of target lesions by CT scan or MRI and chest imaging (CT or Chest x-ray, if clinically indicated) every 3 months (+/- 30 days) for 18 months following end of treatment. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=38 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Progression-Free Survival
|
97 percentage
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment up to 1 year post surgeryPopulation: Subjects were encouraged to complete the assessments but it was left to their discretion. Participants with data available reported.
The MD Anderson Dysphagia Inventory (MDADI) is a 20 item assessment designed to measure voice and swallowing function. Participants were asked 13 symptom questions and 6 interference items (walking, working) and asked id the 1- strongly agree to 5 strongly disagree. Scores were summed for a range of 20-100. The lower the score the worse the outcomes.
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=39 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
n=25 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
n=26 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI)
|
83.90 units on a scale
Standard Deviation 14.04
|
86.26 units on a scale
Standard Deviation 13.24
|
81.90 units on a scale
Standard Deviation 16.56
|
SECONDARY outcome
Timeframe: Pre-treatment up to 1 year post surgeryPopulation: Patients were encouraged to complete the assessment but at their discretion. Participants with data available reported.
The Voice-Related Quality of Life Tool is a 10 item list of possible voice-related problems. The participant answers 1-5 with 1 being none, not a problem to 5, problem is as bad as it can be. An algorithm is used to calculate the scores, so that sum scores range from 0 to 100, where 0 indicates poor V-RQOL and 100 indicates good V-RQOL
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=38 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
n=25 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
n=23 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Voice and Swallowing Function - Voice-Related Quality of Life Assessment (VRQOL)
|
93.42 units on a scale
Standard Deviation 13.20
|
92.00 units on a scale
Standard Deviation 20.12
|
91.85 units on a scale
Standard Deviation 13.80
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: All participants received induction chemotherapy and underwent surgery.
Pathologic complete response (pCR) is the disappearance of all signs of cancer in tissue samples removed during surgery or biopsy (pT0). Also called pathologic complete remission. Pathologic Partial Response (pPR), is the presence of only non-invasive cancer in tissue samples (\<pT2)
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=39 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy
Pathologic complete response (pCR)
|
14 Participants
|
—
|
—
|
|
Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy
Pathologic Partial Response (pPR)
|
25 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: All participants received induction chemotherapy and radiological tumor response evaluation was completed.
Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=39 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Response Rates at the Primary Site
Complete Response
|
15 Participants
|
—
|
—
|
|
Response Rates at the Primary Site
Partial Response
|
21 Participants
|
—
|
—
|
|
Response Rates at the Primary Site
Stable Disease
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 yearsThe NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=40 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Hyperglycemia
|
1 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Alanine aminotransferase increased
|
2 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Aspartate Aminotransferase increased
|
1 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Chest pain- cardiac
|
1 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Diarrhea
|
5 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Fatigue
|
4 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Febrile neutropenia
|
4 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Hyponatremia
|
1 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Hypotension
|
1 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Lymphocyte count decreased
|
1 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Nausea
|
1 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Neutrophil count decreased
|
22 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Palmar-plantar erythrodysesthesia syndrome
|
1 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Peripheral sensory neuropathy
|
2 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Rash acneiform
|
4 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
Sepsis
|
1 Participants
|
—
|
—
|
|
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
White blood cell decreased
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: The data were unable to be analyzed because co-enrollment with LCCC0121 could not be implemented.
Describe the kinome response to induction chemotherapy (lapatinib, paclitaxel, and carboplatin) in patients who consent to this optional evaluation via co-enrollment in LCCC0121
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 11 weeksPopulation: All participants received induction chemotherapy and radiological tumor response evaluation was completed.
Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for neck lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=29 Participants
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
Post-Induction
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
1 Year Post Surgery
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|---|---|
|
Response Rates at the Neck.
Complete Response
|
11 Participants
|
—
|
—
|
|
Response Rates at the Neck.
Partial Response
|
15 Participants
|
—
|
—
|
|
Response Rates at the Neck.
Stable Disease
|
3 Participants
|
—
|
—
|
Adverse Events
Induction Chemotherapy Followed by Transoral Surgery
Serious events: 7 serious events
Other events: 39 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=40 participants at risk
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
2.5%
1/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.5%
1/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Ileus
|
2.5%
1/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
Neutrophil count decreased
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
1/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
White blood cell decreased
|
2.5%
1/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
Other adverse events
| Measure |
Induction Chemotherapy Followed by Transoral Surgery
n=40 participants at risk
All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
|
|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
35.0%
14/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
Platelet count decreased
|
15.0%
6/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
45.0%
18/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Renal and urinary disorders
Urinary tract pain
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
5/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
White blood cell decreased
|
82.5%
33/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
General disorders
Edema face
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
General disorders
Edema limbs
|
10.0%
4/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
4/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
General disorders
Fatigue
|
50.0%
20/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
General disorders
Fever
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
8/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
5/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
8/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.5%
9/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
8/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Vascular disorders
Hypotension
|
7.5%
3/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Psychiatric disorders
Insomnia
|
10.0%
4/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
Lymphocyte count decreased
|
25.0%
10/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
4/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
10/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Nausea
|
55.0%
22/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
Neutrophil count decreased
|
77.5%
31/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
General disorders
Pain
|
12.5%
5/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
7.5%
3/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
5/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
12/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.0%
12/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Blood and lymphatic system disorders
Anemia
|
62.5%
25/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
5/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
3/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
Aspartate aminotransferase increased
|
32.5%
13/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
Blood bilirubin increased
|
15.0%
6/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Eye disorders
Blurred vision
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Constipation
|
30.0%
12/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Investigations
Creatinine increased
|
10.0%
4/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
5/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
28/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
2/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.5%
3/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
Nervous system disorders
Dysgeusia
|
25.0%
10/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
|
General disorders
Dyspepsia
|
7.5%
3/40 • Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place