Trial Outcomes & Findings for Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer (NCT NCT03481114)
NCT ID: NCT03481114
Last Updated: 2026-04-22
Results Overview
Observation of Grade 3 or higher patient-reported toxicity six weeks after chemotherapy radiation was characterized utilizing the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a patient-reported outcome assessment tool developed by the National Cancer Institute (NCI) to capture symptomatic adverse events in patients on cancer clinical trials. Participants completed a customized PRO-CTCAE survey with 24 questions addressing 12 symptoms at baseline, every two weeks during chemoradiotherapy. The number of patients with PRO-CTCAE Grade 3 or higher adverse events was summarized by study arm for each event type.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Up to 6 Weeks after initiation of Chemoradiotherapy
Results posted on
2026-04-22
Participant Flow
55 patients were consented into the study. 5 patients failed to meet inclusion criteria and were excluded from the study. 50 patients were enrolled and randomized into one of the two study arms.
Participant milestones
| Measure |
Standard Chemoradiotherapy (Control Arm)
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy (Dose-Painting Arm)
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
23
|
|
Overall Study
COMPLETED
|
27
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=27 Participants
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy (Dose-Painting Arm)
n=23 Participants
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=27 Participants
|
70 years
n=23 Participants
|
68.9 years
n=50 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=27 Participants
|
14 Participants
n=23 Participants
|
27 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=27 Participants
|
9 Participants
n=23 Participants
|
23 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
27 participants
n=27 Participants
|
23 participants
n=23 Participants
|
50 participants
n=50 Participants
|
|
Clinical Stage
Stage II
|
1 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=50 Participants
|
|
Programmed Cell Death Ligand-1 Protein Expression
≥ 50%
|
6 Participants
n=27 Participants
|
6 Participants
n=23 Participants
|
12 Participants
n=50 Participants
|
|
Clinical Stage
Stage IIIA
|
10 Participants
n=27 Participants
|
13 Participants
n=23 Participants
|
23 Participants
n=50 Participants
|
|
Clinical Stage
Stage IIIB
|
11 Participants
n=27 Participants
|
7 Participants
n=23 Participants
|
18 Participants
n=50 Participants
|
|
Clinical Stage
Stage IIIC
|
4 Participants
n=27 Participants
|
3 Participants
n=23 Participants
|
7 Participants
n=50 Participants
|
|
Clinical Stage
Stage IV
|
1 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=50 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0
|
6 Participants
n=27 Participants
|
6 Participants
n=23 Participants
|
12 Participants
n=50 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1
|
16 Participants
n=27 Participants
|
9 Participants
n=23 Participants
|
25 Participants
n=50 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
2
|
5 Participants
n=27 Participants
|
8 Participants
n=23 Participants
|
13 Participants
n=50 Participants
|
|
Histology, Carcinoma Subtype
Adenocarcinoma
|
12 Participants
n=27 Participants
|
11 Participants
n=23 Participants
|
23 Participants
n=50 Participants
|
|
Histology, Carcinoma Subtype
Squamous Cell Carcinoma
|
10 Participants
n=27 Participants
|
9 Participants
n=23 Participants
|
19 Participants
n=50 Participants
|
|
Histology, Carcinoma Subtype
Other/Not Specified
|
5 Participants
n=27 Participants
|
3 Participants
n=23 Participants
|
8 Participants
n=50 Participants
|
|
Programmed Cell Death Ligand-1 Protein Expression
< 50%
|
14 Participants
n=27 Participants
|
11 Participants
n=23 Participants
|
25 Participants
n=50 Participants
|
|
Adjuvant Systemic Therapy
None
|
6 Participants
n=27 Participants
|
6 Participants
n=23 Participants
|
12 Participants
n=50 Participants
|
|
Programmed Cell Death Ligand-1 Protein Expression
Unknown
|
7 Participants
n=27 Participants
|
6 Participants
n=23 Participants
|
13 Participants
n=50 Participants
|
|
Metabolic Tumor Volume (MTV)
|
41 cubic centimeters
n=27 Participants
|
48 cubic centimeters
n=23 Participants
|
44.2 cubic centimeters
n=50 Participants
|
|
Adjuvant Systemic Therapy
Durvalumab
|
19 Participants
n=27 Participants
|
17 Participants
n=23 Participants
|
36 Participants
n=50 Participants
|
|
Adjuvant Systemic Therapy
Osimertinib
|
2 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Up to 6 Weeks after initiation of ChemoradiotherapyPopulation: 9 patients did not report PRO-CTCAE data at 6 weeks post chemoradiotherapy, 4 in the PET-based, dose-painted arm and 5 in the Standard Chemoradiotherapy (Control Arm). There were no Grade 4 or Grade 5 PRO-CTCAE adverse events during the course of the study.
Observation of Grade 3 or higher patient-reported toxicity six weeks after chemotherapy radiation was characterized utilizing the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a patient-reported outcome assessment tool developed by the National Cancer Institute (NCI) to capture symptomatic adverse events in patients on cancer clinical trials. Participants completed a customized PRO-CTCAE survey with 24 questions addressing 12 symptoms at baseline, every two weeks during chemoradiotherapy. The number of patients with PRO-CTCAE Grade 3 or higher adverse events was summarized by study arm for each event type.
Outcome measures
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=22 Participants
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy,
n=19 Participants
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Dyspnea
|
3 participants
|
0 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Cough
|
6 participants
|
3 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Wheezing
|
3 participants
|
3 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Dermatitis
|
3 participants
|
2 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Dizziness
|
2 participants
|
1 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Fatigue
|
7 participants
|
4 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Anxiety
|
0 participants
|
2 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Anhedonia
|
0 participants
|
2 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Depression
|
1 participants
|
3 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Anorexia
|
5 participants
|
1 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Nausea
|
2 participants
|
3 participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
Dysphagia
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Weeks 19, 32, and 45 on studyLocoregional progression-free survival will be evaluated based on repeat imaging and assessed during the interval from study registration to date of local or regional disease progression or death, whichever comes first, censored at the date of data collection
Outcome measures
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=27 Participants
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy,
n=23 Participants
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
Locoregional Progression-free Survival
Locoregional PFS at 19 weeks
|
93 percentage of participants
|
91 percentage of participants
|
|
Locoregional Progression-free Survival
Locoregional PFS at 32 weeks
|
89 percentage of participants
|
83 percentage of participants
|
|
Locoregional Progression-free Survival
Locoregional PFS at 45 weeks
|
74 percentage of participants
|
83 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 19, 32 and 45 on studyProgression-free survival will be evaluated based on repeat imaging and assessed during the interval from study registration to date of disease progression or death, whichever comes first, censored at the date of data collection. PFS will be summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=27 Participants
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy,
n=23 Participants
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
Progression-free Survival (PFS)
PFS at 19 weeks
|
93 percentage of participants
|
87 percentage of participants
|
|
Progression-free Survival (PFS)
PFS at 32 weeks
|
78 percentage of participants
|
74 percentage of participants
|
|
Progression-free Survival (PFS)
PFS at 45 weeks
|
67 percentage of participants
|
70 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 45 weeksFollow ups will be maintained with study patients to determine survival status. OS will be assessed during the interval from study registration to death, censored at the date of data collection.
Outcome measures
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=27 Participants
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy,
n=23 Participants
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
Overall Survival (OS)
OS at 19 weeks
|
95 percentage of participants
|
91 percentage of participants
|
|
Overall Survival (OS)
OS at 32 weeks
|
89 percentage of participants
|
83 percentage of participants
|
|
Overall Survival (OS)
OS at 45 weeks
|
78 percentage of participants
|
83 percentage of participants
|
SECONDARY outcome
Timeframe: From treatment start through study week 45Population: All events identified below were Grade 3
Evaluation of any Grade 3-5 adverse events, including Grade 3-5 side effects and toxicities, were assessed based on CTCAE Version 4.0. Adverse events/side effects/toxicities have been summarized by study arm. The number/percentage of patients with Grade 3-5 adverse events, scored using CTCAE Version 4.0, is summarized by study arm.
Outcome measures
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=27 Participants
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy,
n=23 Participants
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
Number of Patients With Grade 3-5 Adverse Events, Scored Using CTCAE Version 4.0
Esophagitis
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3-5 Adverse Events, Scored Using CTCAE Version 4.0
Dermatitis
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Adverse Events, Scored Using CTCAE Version 4.0
Pneumonitis
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From treatment start through study week 45Population: There were no Grade 4 or Grade 5 PRO-CTCAE adverse events during the course of the study.
Evaluation of severe, patient reported side effects or toxicities was assessed. The number/percentage of patients with PRO-CTCAE, scored using CTCAE Version 4.0, is summarized by study arm.
Outcome measures
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=27 Participants
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy,
n=23 Participants
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Anhedonia
|
1 Participants
|
4 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Depression
|
2 Participants
|
4 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Dysphagia
|
10 Participants
|
9 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Anorexia
|
7 Participants
|
5 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Nausea
|
3 Participants
|
5 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Dyspnea
|
7 Participants
|
3 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Cough
|
9 Participants
|
7 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Wheezing
|
9 Participants
|
5 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Dermatitis
|
5 Participants
|
2 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Dizziness
|
4 Participants
|
3 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Fatigue
|
10 Participants
|
9 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time
Anxiety
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From treatment start through study week 45Population: There were no Grade 4 or Grade 5 PRO-CTCAE adverse events during the course of the study.
Evaluation of any patient reported side effects or toxicities. This Outcome Measure includes PRO-CTCAE AEs that were Grades 0, 1, or 2. The number of patients with Grade 3 PRO-CTCAE have been summarized in the corresponding Outcome Measure.
Outcome measures
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=27 Participants
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy,
n=23 Participants
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Dysphagia
|
10 Participants
|
10 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Anorexia
|
8 Participants
|
8 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Nausea
|
3 Participants
|
5 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Dyspnea
|
8 Participants
|
5 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Cough
|
11 Participants
|
7 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Wheezing
|
10 Participants
|
6 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Dermatitis
|
6 Participants
|
4 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Dizziness
|
5 Participants
|
3 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Fatigue
|
13 Participants
|
11 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Anxiety
|
5 Participants
|
7 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Anhedonia
|
2 Participants
|
6 Participants
|
|
Number of Patients With PRO-CTCAE Adverse Events With Any Score
Depression
|
4 Participants
|
7 Participants
|
Adverse Events
Standard Chemoradiotherapy (Control Arm)
Serious events: 4 serious events
Other events: 27 other events
Deaths: 15 deaths
PET-based, Dose-painted, Accelerated Chemoradiotherapy (Dose-Painting Arm)
Serious events: 6 serious events
Other events: 23 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=27 participants at risk
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy (Dose-Painting Arm)
n=23 participants at risk
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
General disorders
Dyspnea
|
3.7%
1/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Stroke
|
0.00%
0/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
Other adverse events
| Measure |
Standard Chemoradiotherapy (Control Arm)
n=27 participants at risk
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course.
|
PET-based, Dose-painted, Accelerated Chemoradiotherapy (Dose-Painting Arm)
n=23 participants at risk
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
14.8%
4/27 • Up to 5 years following treatment.
|
17.4%
4/23 • Up to 5 years following treatment.
|
|
Musculoskeletal and connective tissue disorders
Difficulty elevating arm
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
14.8%
4/27 • Up to 5 years following treatment.
|
17.4%
4/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
General disorders
Dyspnea
|
74.1%
20/27 • Up to 5 years following treatment.
|
73.9%
17/23 • Up to 5 years following treatment.
|
|
Renal and urinary disorders
Dysuria
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
77.8%
21/27 • Up to 5 years following treatment.
|
87.0%
20/23 • Up to 5 years following treatment.
|
|
General disorders
Fatigue
|
85.2%
23/27 • Up to 5 years following treatment.
|
82.6%
19/23 • Up to 5 years following treatment.
|
|
General disorders
Fever
|
3.7%
1/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease (GERD)
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Hand tremor
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Vascular disorders
Hematoma
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
7.4%
2/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Investigations
Cholesterol high
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.4%
2/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/27 • Up to 5 years following treatment.
|
13.0%
3/23 • Up to 5 years following treatment.
|
|
Vascular disorders
Hypertension
|
7.4%
2/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.7%
1/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Infections and infestations
Influenza
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Investigations
Lymphocyte count decreased
|
7.4%
2/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.7%
1/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Nausea
|
37.0%
10/27 • Up to 5 years following treatment.
|
30.4%
7/23 • Up to 5 years following treatment.
|
|
Investigations
Neutrophil count decreased
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
7.4%
2/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Paresthesia
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
General disorders
Perianal growth
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
General disorders
Peripheral edema
|
3.7%
1/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Peripheral neuropathy
|
3.7%
1/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Investigations
Platelet count decreased
|
7.4%
2/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
1/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
22.2%
6/27 • Up to 5 years following treatment.
|
17.4%
4/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Right Upper Lobe Opacity
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Musculoskeletal and connective tissue disorders
Restricted mobility
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Seizure
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
General disorders
Sleep impairment
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Cardiac disorders
Tachycardia
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Renal and urinary disorders
Urinary retention
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alterations
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Investigations
White blood cell (WBC) decreased
|
18.5%
5/27 • Up to 5 years following treatment.
|
21.7%
5/23 • Up to 5 years following treatment.
|
|
Investigations
Weight loss
|
7.4%
2/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
6/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
81.5%
22/27 • Up to 5 years following treatment.
|
87.0%
20/23 • Up to 5 years following treatment.
|
|
Investigations
Creatinine increased
|
3.7%
1/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.8%
4/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
70.4%
19/27 • Up to 5 years following treatment.
|
43.5%
10/23 • Up to 5 years following treatment.
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
3.7%
1/27 • Up to 5 years following treatment.
|
13.0%
3/23 • Up to 5 years following treatment.
|
|
Investigations
Aspartate aminotransferase (AST) increased
|
0.00%
0/27 • Up to 5 years following treatment.
|
17.4%
4/23 • Up to 5 years following treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.7%
1/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
6/27 • Up to 5 years following treatment.
|
34.8%
8/23 • Up to 5 years following treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
1/27 • Up to 5 years following treatment.
|
8.7%
2/23 • Up to 5 years following treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Cardiac disorders
Atrial Flutter/Tachycardia
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.4%
2/27 • Up to 5 years following treatment.
|
21.7%
5/23 • Up to 5 years following treatment.
|
|
Investigations
Blood bilirubin increased
|
3.7%
1/27 • Up to 5 years following treatment.
|
0.00%
0/23 • Up to 5 years following treatment.
|
|
General disorders
Chest pain
|
18.5%
5/27 • Up to 5 years following treatment.
|
17.4%
4/23 • Up to 5 years following treatment.
|
|
General disorders
Chills
|
0.00%
0/27 • Up to 5 years following treatment.
|
4.3%
1/23 • Up to 5 years following treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place