Trial Outcomes & Findings for Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence (NCT NCT01824823)
NCT ID: NCT01824823
Last Updated: 2023-06-28
Results Overview
DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registration
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
Arm A (Afatinib)
Patients receive afatinib PO QD on days 1-28.
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Arm A (Afatinib)
Patients receive afatinib PO QD on days 1-28.
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Off-treatment reason not submitted
|
1
|
0
|
Baseline Characteristics
Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence
Baseline characteristics by cohort
| Measure |
Arm A (Afatinib)
n=2 Participants
Patients receive afatinib PO QD on days 1-28.
|
Arm B (Placebo)
n=1 Participants
Patients receive placebo PO QD on days 1-28.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registrationPopulation: All randomized patients
DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.
Outcome measures
| Measure |
Arm A (Afatinib)
n=2 Participants
Patients receive afatinib PO QD on days 1-28.
|
Arm B (Placebo)
n=1 Participants
Patients receive placebo PO QD on days 1-28.
|
|---|---|---|
|
Disease-free Survival (DFS)
|
NA months
Interval 5.2 to
The estimated median DFS was not available by definition in the survival setting. The upper limit of the 95% CI was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
NA months
Individual data could not be reported for patient privacy reasons as only 1 patient was enrolled in this arm.
|
Adverse Events
Arm A (Afatinib)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm B (Placebo)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Afatinib)
n=2 participants at risk
Patients receive afatinib PO QD on days 1-28.
|
Arm B (Placebo)
n=1 participants at risk
Patients receive placebo PO QD on days 1-28.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Arm A (Afatinib)
n=2 participants at risk
Patients receive afatinib PO QD on days 1-28.
|
Arm B (Placebo)
n=1 participants at risk
Patients receive placebo PO QD on days 1-28.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
100.0%
2/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
2/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
White blood cell decreased
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Spasticity
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
Additional Information
Study Statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60