Trial Outcomes & Findings for Cisplatin and Etoposide Plus Radiation Followed By Nivolumab/Placebo For Locally Advanced NSCLC (NCT NCT02768558)
NCT ID: NCT02768558
Last Updated: 2021-06-02
Results Overview
Survival time is defined as time from registration to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported and no statistical testing was done.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
From registration to study termination. Maximum follow-up was 14.9 months.
Results posted on
2021-06-02
Participant Flow
Registered patients who submitted tissue for PD-L1 assessment and had no evidence of distant metastases or local disease progression at the second step registration were randomized. Of 20 registered patients, 8 were randomized.
Participant milestones
| Measure |
Nivolumab
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
|
Placebo
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
Eligible
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cisplatin and Etoposide Plus Radiation Followed By Nivolumab/Placebo For Locally Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Nivolumab
n=3 Participants
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
|
Placebo
n=5 Participants
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
64 years
n=7 Participants
|
67.5 years
n=5 Participants
|
|
Age, Customized
50-59 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Customized
≥ 70 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Zubrod Performance Status
0
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Zubrod Performance Status
1
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
PD-L1
< 1%
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
PD-L1
≥ 1%
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
PD-L1
Not Evaluable
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From registration to study termination. Maximum follow-up was 14.9 months.Population: Eligible participants
Survival time is defined as time from registration to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported and no statistical testing was done.
Outcome measures
| Measure |
Nivolumab
n=3 Participants
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
|
Placebo
n=5 Participants
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
|
|---|---|---|
|
Overall Survival (OS)
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From registration to study termination. Maximum follow-up was 14.9 months.Population: Central review of imaging to determine progression was not performed due to early study closure therefore progression (and hence progression-free survival) could not be determined.
Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression was to be determined by an independent radiology review committee using scans submitted to a central location. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored) and was to be estimated by the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From registration to study termination. Maximum follow-up was 14.9 months.Population: Eligible participants
Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Nivolumab
n=3 Participants
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
|
Placebo
n=5 Participants
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
|
|---|---|---|
|
Number of Participants With Grade 3+ Adverse Events
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 15 monthsPopulation: No participants had a 15-month FACT-TOI assessment
FACT-TOI is a measure of 21 items that sum the functional well being (FWB), physical well being (PWB), and the lung cancer subscale (LCS) of the Functional Assessment of Cancer Therapy - Lung (FACT-L) QOL instrument, used for measuring QOL in patients with lung cancer. All items are rated on a 5 item (point) Likert Scale, from 0 (not at all) to 4 (very much). FACT-TOI is scored by summing the individual scale scores, with higher scores indicating better quality of life. Deterioration was defined as a decrease of 5 points or more from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From registration to study termination. Maximum follow-up was 14.9 months.Population: Data is not reported because the primary endpoints were not determined to have positive results. \[Per the protocol, this subgroup analysis was to occur only if either of the primary endpoints were determined to have positive results.\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From registration to study termination. Maximum follow-up was 14.9 months.Population: Data is not reported because the primary endpoints were not determined to have positive results. \[Per the protocol, this subgroup analysis was to occur only if either of the primary endpoints were determined to have positive results.\]
Outcome measures
Outcome data not reported
Adverse Events
Nivolumab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivolumab
n=3 participants at risk
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
|
Placebo
n=5 participants at risk
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
General disorders
Death NOS
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
Other adverse events
| Measure |
Nivolumab
n=3 participants at risk
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
|
Placebo
n=5 participants at risk
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
|
|---|---|---|
|
General disorders
Fatigue
|
100.0%
3/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
100.0%
5/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
General disorders
General disorders and administration site conditions - Other
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
General disorders
Malaise
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
General disorders
Pain
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Immune system disorders
Immune system disorders - Other
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
100.0%
5/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Ear and labyrinth disorders
Hearing impaired
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Ear and labyrinth disorders
Tinnitus
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
60.0%
3/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Dysphagia
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
80.0%
4/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Esophagitis
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Gastroparesis
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Investigations - Other
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Serum amylase increased
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Urine output decreased
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
Weight loss
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
60.0%
3/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Nervous system disorders
Dysgeusia
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Nervous system disorders
Nervous system disorders - Other
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Psychiatric disorders
Anxiety
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Psychiatric disorders
Confusion
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Renal and urinary disorders
Urinary urgency
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
3/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
40.0%
2/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
20.0%
1/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
66.7%
2/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
|
Vascular disorders
Superficial thrombophlebitis
|
33.3%
1/3 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
0.00%
0/5 • Adverse events were to be reported every 3 months until 2 years post-chemoradiation, then every 6 months until 5 years post-chemoradiation, then yearly until study termination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER