Trial Outcomes & Findings for Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer (NCT NCT00066742)
NCT ID: NCT00066742
Last Updated: 2014-05-15
Results Overview
Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.
Results posted on
2014-05-15
Participant Flow
Between 9/2003 and 7/2006, 72 of planned 85 limited smal-cell lung cancer patients were enrolled by SWOG institutions. The study was closed early due to a report of excess toxicity for Tirapazamine in a head and neck cancer trial elsewhere.
Participant milestones
| Measure |
Evaluable Patients
Only eligible patients who received the study intervention were included in the analysis.
|
|---|---|
|
Induction Chemoradiotherapy
STARTED
|
72
|
|
Induction Chemoradiotherapy
Eligible
|
69
|
|
Induction Chemoradiotherapy
Began Protocol Treatment
|
68
|
|
Induction Chemoradiotherapy
COMPLETED
|
43
|
|
Induction Chemoradiotherapy
NOT COMPLETED
|
29
|
|
Consolidation Chemotherapy
STARTED
|
42
|
|
Consolidation Chemotherapy
Eligible
|
40
|
|
Consolidation Chemotherapy
COMPLETED
|
39
|
|
Consolidation Chemotherapy
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Evaluable Patients
Only eligible patients who received the study intervention were included in the analysis.
|
|---|---|
|
Induction Chemoradiotherapy
Did not receive any protocol treatment
|
1
|
|
Induction Chemoradiotherapy
Adverse Event
|
21
|
|
Induction Chemoradiotherapy
Withdrawal by Subject
|
2
|
|
Induction Chemoradiotherapy
not protocol specified
|
2
|
|
Induction Chemoradiotherapy
Ineligible
|
3
|
|
Consolidation Chemotherapy
not protocol specified
|
1
|
|
Consolidation Chemotherapy
Ineligible
|
2
|
Baseline Characteristics
Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Evaluable Patients
n=68 Participants
Only eligible patients who received the study intervention were included in the analysis.
|
|---|---|
|
Age, Continuous
|
63 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.Population: Only eligible patients who received protocol treatment were included in the analsysis.
Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.
Outcome measures
| Measure |
Evaluable Patients
n=68 Participants
|
|---|---|
|
Overall Survival
|
21 months
Interval 17.0 to 32.0
|
SECONDARY outcome
Timeframe: After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment.Population: Only eligible patients who received protocol treatment were included in the analysis.
A complete response (CR) was defined as a complete disappearance of all disease with no new lesions. A partial response (PR) was defined as at least a 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. Both CR and PR had to be confirmed by a second determination at least 4 weeks apart. All disease had to be assessed using same method as baseline. Only patients with measurable disease at baseline were included in this analysis.
Outcome measures
| Measure |
Evaluable Patients
n=63 Participants
|
|---|---|
|
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.
Complete Response
|
0 participants
|
|
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.
Unconfirmed Complete Response
|
7 participants
|
|
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.
Partial Response
|
2 participants
|
|
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.
Unconfirmed Partial Response
|
30 participants
|
|
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.
No response
|
24 participants
|
SECONDARY outcome
Timeframe: At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment.Progression was defined as a \>= 20% increase in the sum of longest diameters of measurable lesions over the smallest sum observed or unequivocal progression of non-measurable disease or the appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring discontinuation of treatment. Progression-free survival was defined as the time from the date of enrollment until the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.
Outcome measures
| Measure |
Evaluable Patients
n=68 Participants
|
|---|---|
|
Progression-Free Survival
|
11 months
Interval 10.0 to 13.0
|
Adverse Events
Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy
Serious events: 24 serious events
Other events: 67 other events
Deaths: 0 deaths
Consolidation Cisplatin + Etoposide
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy
n=68 participants at risk
|
Consolidation Cisplatin + Etoposide
n=39 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
2/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
5.1%
2/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.9%
2/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Esophagitis
|
10.3%
7/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Hemorrhage, GI - Esophagus
|
0.00%
0/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Esophagus
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Pain - Esophagus
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
4/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
|
0.00%
0/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Catheter-rela
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Leukocytes (total WBC)
|
8.8%
6/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
7.7%
3/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
10.3%
7/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Platelets
|
5.9%
4/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
5.1%
2/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Weight loss
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
2/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Dehydration
|
19.1%
13/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
5.9%
4/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death not associated with CTCAE term - Disease progression NOS
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Psychiatric disorders
Confusion
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
2.6%
1/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Vascular disorders
Hypotension
|
1.5%
1/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.9%
2/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
Other adverse events
| Measure |
Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy
n=68 participants at risk
|
Consolidation Cisplatin + Etoposide
n=39 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.8%
6/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
10.3%
4/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Blood and lymphatic system disorders
Hemoglobin
|
72.1%
49/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
82.1%
32/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Ear and labyrinth disorders
Tinnitus
|
5.9%
4/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Constipation
|
47.1%
32/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
20.5%
8/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Diarrhea
|
32.4%
22/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
15.4%
6/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
47.1%
32/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
33.3%
13/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Esophagitis
|
47.1%
32/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
30.8%
12/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
7.4%
5/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
5.1%
2/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
7.4%
5/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
7.7%
3/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
19.1%
13/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
15.4%
6/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Nausea
|
72.1%
49/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
46.2%
18/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
5.9%
4/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
5.1%
2/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Vomiting
|
44.1%
30/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
28.2%
11/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
79.4%
54/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
76.9%
30/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
|
11.8%
8/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
10.3%
4/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
General disorders
Rigors/chills
|
8.8%
6/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
7.7%
3/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
|
0.00%
0/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
5.1%
2/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation - Radiation
|
22.1%
15/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
14.7%
10/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
5.1%
2/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
7.4%
5/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Alkaline phosphatase
|
7.4%
5/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
5.1%
2/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
5.9%
4/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Creatinine
|
10.3%
7/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
10.3%
4/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Leukocytes (total WBC)
|
76.5%
52/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
76.9%
30/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
70.6%
48/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
76.9%
30/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Platelets
|
60.3%
41/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
61.5%
24/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Weight loss
|
38.2%
26/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
33.3%
13/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
13.2%
9/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
5.1%
2/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Anorexia
|
14.7%
10/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
15.4%
6/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
27.9%
19/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
17.9%
7/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Dehydration
|
30.9%
21/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
23.1%
9/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
16.2%
11/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
15.4%
6/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
27.9%
19/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
23.1%
9/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
10.3%
7/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
17.9%
7/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
11.8%
8/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
7.7%
3/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
8.8%
6/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.00%
0/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
7.7%
3/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
47.1%
32/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
20.5%
8/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Nervous system disorders
Neuropathy: sensory
|
11.8%
8/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
15.4%
6/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
27.9%
19/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
10.3%
4/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.8%
6/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
7.7%
3/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
5.1%
2/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
66.2%
45/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
66.7%
26/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
11.8%
8/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
0.00%
0/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Vascular disorders
Hypotension
|
20.6%
14/68 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
7.7%
3/39 • Patients were assessed for adverse events weekly during concurrent radiotherapy, and every 3 weeks during consolidation chemotherapy.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
Additional Information
Lung Committee Statistician
SWOG Statistical Center
Phone: 206-652-2267
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60