Trial Outcomes & Findings for Platinum Doublet Chemotherapy and Proton Beam Radiation Therapy in Treating Patients With Stage II-III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (NCT NCT03132532)
NCT ID: NCT03132532
Last Updated: 2025-11-25
Results Overview
A Cox proportional hazards model stratified by stratification factors will be used to model PFS as a function of dose to test for an overall dose effect (a one-sided p-value \< 0.10 will be considered as significant evidence of a dose effect). Subsequently, separate Cox models stratified by stratification factors will compare PFS between 72 Gy and 60 Gy (for each, a one-sided p-value \< 0.10 will be considered as significant evidence of superiority). Kaplan Meier estimates and curves by dose level will also be generated
COMPLETED
PHASE2
20 participants
From randomization to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
2025-11-25
Participant Flow
Participant milestones
| Measure |
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.\> \> Carboplatin: Chemotherapy\>
\> Cisplatin: Chemotherapy\>
\> Etoposide: Chemotherapy\>
\> Paclitaxel: Chemotherapy\>
\> Pemetrexed: Chemotherapy\>
\> Proton Beam Radiation Therapy: Undergo PBT\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.\>
\> Carboplatin: Chemotherapy\>
\> Paclitaxel: Chemotherapy\>
\> Proton Beam Radiation Therapy: Undergo PBT\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One patient on Arm C is missing ECOG data
Baseline characteristics by cohort
| Measure |
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.\> \> Carboplatin: Chemotherapy\>
\> Cisplatin: Chemotherapy\>
\> Etoposide: Chemotherapy\>
\> Paclitaxel: Chemotherapy\>
\> Pemetrexed: Chemotherapy\>
\> Proton Beam Radiation Therapy: Undergo PBT\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.\>
\> Carboplatin: Chemotherapy\>
\> Paclitaxel: Chemotherapy\>
\> Proton Beam Radiation Therapy: Undergo PBT\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.50 years
n=10 Participants
|
74.0 years
n=7 Participants
|
74.0 years
n=17 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=10 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=10 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=17 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Method of Payment
MEDICARE
|
9 Participants
n=10 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=17 Participants
|
|
Method of Payment
MEDICARE AND PRIVATE INSURANCE
|
1 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=17 Participants
|
|
Method of Payment
PRIVATE INSURANCE
|
0 Participants
n=10 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=17 Participants
|
|
Height (Cm)
|
167.100 cm
STANDARD_DEVIATION 11.799 • n=10 Participants
|
171.714 cm
STANDARD_DEVIATION 10.965 • n=7 Participants
|
169.000 cm
STANDARD_DEVIATION 11.352 • n=17 Participants
|
|
Weight (Kg)
|
73.460 Kg
STANDARD_DEVIATION 13.422 • n=10 Participants
|
84.900 Kg
STANDARD_DEVIATION 18.190 • n=7 Participants
|
78.171 Kg
STANDARD_DEVIATION 16.096 • n=17 Participants
|
|
Smoking Cessation
Quit
|
8 Participants
n=10 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=17 Participants
|
|
Smoking Cessation
Kept smoking
|
2 Participants
n=10 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=17 Participants
|
|
Smoking Cessation
Non-smoker
|
0 Participants
n=10 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=17 Participants
|
|
Baseline QOL
60
|
0 Participants
n=10 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=17 Participants
|
|
Baseline QOL
70
|
0 Participants
n=10 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=17 Participants
|
|
Baseline QOL
80
|
2 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=17 Participants
|
|
Baseline QOL
90
|
5 Participants
n=10 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=17 Participants
|
|
Baseline QOL
100
|
3 Participants
n=10 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=17 Participants
|
|
ECOG Performance Status
0
|
3 Participants
n=10 Participants • One patient on Arm C is missing ECOG data
|
3 Participants
n=6 Participants • One patient on Arm C is missing ECOG data
|
6 Participants
n=16 Participants • One patient on Arm C is missing ECOG data
|
|
ECOG Performance Status
1
|
7 Participants
n=10 Participants • One patient on Arm C is missing ECOG data
|
3 Participants
n=6 Participants • One patient on Arm C is missing ECOG data
|
10 Participants
n=16 Participants • One patient on Arm C is missing ECOG data
|
|
Mayo prognostic score
32-37
|
0 Participants
n=10 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=17 Participants
|
|
Mayo prognostic score
38-43
|
4 Participants
n=10 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=17 Participants
|
|
Mayo prognostic score
44-47
|
4 Participants
n=10 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=17 Participants
|
|
Mayo prognostic score
48-52
|
2 Participants
n=10 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: From randomization to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 yearsA Cox proportional hazards model stratified by stratification factors will be used to model PFS as a function of dose to test for an overall dose effect (a one-sided p-value \< 0.10 will be considered as significant evidence of a dose effect). Subsequently, separate Cox models stratified by stratification factors will compare PFS between 72 Gy and 60 Gy (for each, a one-sided p-value \< 0.10 will be considered as significant evidence of superiority). Kaplan Meier estimates and curves by dose level will also be generated
Outcome measures
| Measure |
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Cisplatin: Chemotherapy
\>
\> Etoposide: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Pemetrexed: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Proportion of Participants With Progression Free Survival (PFS)
|
0.429 proportion of participants
Interval 0.182 to 1.0
|
0.6 proportion of participants
Interval 0.362 to 0.995
|
SECONDARY outcome
Timeframe: From randomization to death due to any cause, assessed up to 5 yearsWill be modeled using Cox models. Kaplan-Meier estimates and curves by dose level will also be generated. OS will again be analyzed as exploratory analysis after 50 deaths per primary pairwise comparison have occurred or after all patients have completed follow-up (whichever occurs first).
Outcome measures
| Measure |
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Cisplatin: Chemotherapy
\>
\> Etoposide: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Pemetrexed: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Survival (OS)
Alive
|
2 Participants
|
4 Participants
|
|
Overall Survival (OS)
Dead
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsGraded by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events are graded on a scale of 0-5 with 5 being worst. The number of participants with Grade 2 or higher adverse events will be reported.
Outcome measures
| Measure |
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Cisplatin: Chemotherapy
\>
\> Etoposide: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Pemetrexed: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Number of Participants With Adverse Events
AE Grade 2+
|
6 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events
AE Grade 3+
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsDefined as the proportion of participants with documentation of local recurrence. The cumulative incidence of local failure will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk).
Outcome measures
| Measure |
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=8 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Cisplatin: Chemotherapy
\>
\> Etoposide: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Pemetrexed: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Proportion of Participants With Local-regional Failure
|
0.14 proportion of participants
Interval 0.026 to 0.51
|
0.2 proportion of participants
Interval 0.057 to 0.51
|
SECONDARY outcome
Timeframe: Up to 5 yearsDefined as the proportion of participants with documentation of distant metastasis. The cumulative incidence of distant metastasis will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk).
Outcome measures
| Measure |
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.
\>
\> Carboplatin: Chemotherapy
\>
\> Cisplatin: Chemotherapy
\>
\> Etoposide: Chemotherapy
\>
\> Paclitaxel: Chemotherapy
\>
\> Pemetrexed: Chemotherapy
\>
\> Proton Beam Radiation Therapy: Undergo PBT
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Proportion of Participants With Distant Metastasis
|
0.29 proportion of participants
Interval 0.08 to 0.64
|
0.1 proportion of participants
Interval 0.018 to 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsMeasured using the single item Linear Analogue Self-Assessment scale. Descriptive statistics by dose level at each time point will include means, standard deviations, medians, and ranges for each scale. Descriptive graphical techniques will include mean plots by dose over time for each scale. Mixed models will be used to compare each scale across dose levels at each post-baseline time point while adjusting for the baseline value of scale. Will graphically explore patterns of missing data and will employ pattern mixture models for longitudinal analyses. The lowest number measuring worst and higher number measuring best outcome.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
Serious adverse events
| Measure |
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=9 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
General disorders
Death NOS
|
50.0%
5/10 • Number of events 5 • Up to 5 years
|
55.6%
5/9 • Number of events 5 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/10 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
Other adverse events
| Measure |
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=9 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Gastrointestinal disorders
Esophageal pain
|
10.0%
1/10 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
70.0%
7/10 • Number of events 15 • Up to 5 years
|
77.8%
7/9 • Number of events 11 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 5 • Up to 5 years
|
44.4%
4/9 • Number of events 4 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
General disorders
Fatigue
|
80.0%
8/10 • Number of events 16 • Up to 5 years
|
66.7%
6/9 • Number of events 9 • Up to 5 years
|
|
General disorders
Pain
|
20.0%
2/10 • Number of events 2 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
60.0%
6/10 • Number of events 6 • Up to 5 years
|
77.8%
7/9 • Number of events 7 • Up to 5 years
|
|
Investigations
Weight loss
|
30.0%
3/10 • Number of events 3 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 1 • Up to 5 years
|
33.3%
3/9 • Number of events 3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
5/10 • Number of events 7 • Up to 5 years
|
55.6%
5/9 • Number of events 5 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
70.0%
7/10 • Number of events 16 • Up to 5 years
|
77.8%
7/9 • Number of events 10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
80.0%
8/10 • Number of events 18 • Up to 5 years
|
55.6%
5/9 • Number of events 7 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
40.0%
4/10 • Number of events 5 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/10 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
60.0%
6/10 • Number of events 8 • Up to 5 years
|
22.2%
2/9 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
90.0%
9/10 • Number of events 18 • Up to 5 years
|
44.4%
4/9 • Number of events 4 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place