Trial Outcomes & Findings for S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors (NCT NCT00062439)
NCT ID: NCT00062439
Last Updated: 2013-11-25
Results Overview
Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel
Results posted on
2013-11-25
Participant Flow
Participant milestones
| Measure |
Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
|
|---|---|
|
Induction Chemotherapy + Radiotherapy
STARTED
|
46
|
|
Induction Chemotherapy + Radiotherapy
COMPLETED
|
38
|
|
Induction Chemotherapy + Radiotherapy
NOT COMPLETED
|
8
|
|
Post Chemoradiation Assessment
STARTED
|
38
|
|
Post Chemoradiation Assessment
COMPLETED
|
29
|
|
Post Chemoradiation Assessment
NOT COMPLETED
|
9
|
|
Surgery
STARTED
|
29
|
|
Surgery
COMPLETED
|
22
|
|
Surgery
NOT COMPLETED
|
7
|
|
Consolidation Chemotherapy
STARTED
|
22
|
|
Consolidation Chemotherapy
COMPLETED
|
20
|
|
Consolidation Chemotherapy
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
|
|---|---|
|
Induction Chemotherapy + Radiotherapy
Ineligible
|
1
|
|
Induction Chemotherapy + Radiotherapy
Refused protocol treatment
|
1
|
|
Induction Chemotherapy + Radiotherapy
Adverse Event
|
3
|
|
Induction Chemotherapy + Radiotherapy
Lack of Efficacy
|
3
|
|
Post Chemoradiation Assessment
Death
|
1
|
|
Post Chemoradiation Assessment
Disease progression
|
2
|
|
Post Chemoradiation Assessment
Withdrawal by Subject
|
1
|
|
Post Chemoradiation Assessment
Physician Decision
|
1
|
|
Post Chemoradiation Assessment
Not eligible to continue to surgery
|
4
|
|
Surgery
Physician Decision
|
4
|
|
Surgery
Death
|
1
|
|
Surgery
Adverse Event
|
2
|
|
Consolidation Chemotherapy
Adverse Event
|
2
|
Baseline Characteristics
S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
Baseline characteristics by cohort
| Measure |
Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
n=44 Participants
Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
|
|---|---|
|
Age Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxelPopulation: Eligible patients who began the treatment regimen were included in the analysis.
Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.
Outcome measures
| Measure |
Induction Cisplatin/Etoposide + XRT
n=44 Participants
|
Surgery
|
Consolidation Docetaxel
|
|---|---|---|---|
|
Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel.
|
45 percentage of participants
Interval 30.0 to 61.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.Population: Eligible patients who received the study intervention.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Induction Cisplatin/Etoposide + XRT
n=44 Participants
|
Surgery
n=29 Participants
|
Consolidation Docetaxel
n=22 Participants
|
|---|---|---|---|
|
Adverse Events
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Adverse Events
Inf (clin/microbio) w/Gr 3-4 neuts - Wound
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Adverse Events
Inf w/normal ANC or Gr 1-2 neutrophils - Meninges
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Inf w/normal ANC or Gr 1-2 neutrophils - Wound
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Infection with unknown ANC - Lung (pneumonia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Infection with unknown ANC - Wound
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Leak, cerebrospinal fluid (CSF)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Leukocytes (total WBC)
|
11 Participants
|
0 Participants
|
6 Participants
|
|
Adverse Events
Lymphopenia
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Adverse Events
Metabolic/Laboratory-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Nausea
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Neutrophils/granulocytes (ANC/AGC)
|
15 Participants
|
0 Participants
|
8 Participants
|
|
Adverse Events
Pain - Chest wall
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Pain - Extremity-limb
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Pain-Other (Specify)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Platelets
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Pulmonary/Upper Respiratory-Other (Specify)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Adult respiratory distress syndrome (ARDS)
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Adverse Events
Allergic reaction/hypersensitivity
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Chylothorax
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Adverse Events
Dehydration
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Adverse Events
Diarrhea
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Dyspnea (shortness of breath)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Adverse Events
Esophagitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Fatigue (asthenia, lethargy, malaise)
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Febrile neutropenia
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Fistula, pulmonary/upper respiratory - Bronchus
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Fistula, pulmonary/upper respiratory - Lung
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Glucose, serum-high (hyperglycemia)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Adverse Events
Hemoglobin
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Adverse Events
Hemorrhage/bleeding w/surgery, intra- or post-op
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Hypoxia
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Adverse Events
Mucositis/stomatitis (clinical exam) - Esophagus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
SVT and nodal arrhythmia - Atrial fibrillation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Sodium, serum-low (hyponatremia)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Thrombosis/thrombus/embolism
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Ventricular arrhythmia - Ventricular fibrillation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Vomiting
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Weight loss
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.Population: Eligible patients who began the treatment regimen were included in the analysis.
The duration from the 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 contact.
Outcome measures
| Measure |
Induction Cisplatin/Etoposide + XRT
n=44 Participants
|
Surgery
|
Consolidation Docetaxel
|
|---|---|---|---|
|
Overall Survival
|
4 years
Interval 2.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment.Population: Eligible patients who began the treatment regimen were included in the analysis.
Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.
Outcome measures
| Measure |
Induction Cisplatin/Etoposide + XRT
n=44 Participants
|
Surgery
|
Consolidation Docetaxel
|
|---|---|---|---|
|
Progression-Free Survival at 3 Years
|
56 percentage of patients
Interval 40.0 to 70.0
|
—
|
—
|
SECONDARY outcome
Timeframe: After completion of induction therapy.Population: Eligible patients who began the treatment regimen and who had measurable disease (per RECIST) at baseline were included in the analysis of response.
Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a \>= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart.
Outcome measures
| Measure |
Induction Cisplatin/Etoposide + XRT
n=32 Participants
|
Surgery
|
Consolidation Docetaxel
|
|---|---|---|---|
|
Response
|
28 percentage of participants
Interval 14.0 to 47.0
|
—
|
—
|
Adverse Events
Induction Cisplatin/Etoposide + XRT
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Surgery
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Consolidation Docetaxel
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Cisplatin/Etoposide + XRT
n=44 participants at risk
|
Surgery
n=29 participants at risk
|
Consolidation Docetaxel
n=22 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Esophagus
|
2.3%
1/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
2.3%
1/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
3.4%
1/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Infections and infestations
Infection with unknown ANC - Wound
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
3.4%
1/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
Leukocytes (total WBC)
|
2.3%
1/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
Other adverse events
| Measure |
Induction Cisplatin/Etoposide + XRT
n=44 participants at risk
|
Surgery
n=29 participants at risk
|
Consolidation Docetaxel
n=22 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
63.6%
28/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
55.2%
16/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
59.1%
13/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial flutter
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Cardiac disorders
SVT and nodal arrhythmia - SVT arrhythmia NOS
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
13.8%
4/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Gastrointestinal disorders
Constipation
|
38.6%
17/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
22.7%
5/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
20.5%
9/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
22.7%
5/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
27.3%
12/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Gastrointestinal disorders
Esophagitis
|
22.7%
10/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
9.1%
4/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
13.6%
3/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
9.1%
4/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Gastrointestinal disorders
Nausea
|
72.7%
32/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
27.3%
6/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
38.6%
17/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
18.2%
4/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
General disorders
Edema: head and neck
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
72.7%
32/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
54.5%
12/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
6.8%
3/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
17.2%
5/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
18.2%
4/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
General disorders
Pain-Other (Specify)
|
27.3%
12/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
31.8%
7/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
General disorders
Rigors/chills
|
11.4%
5/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Wound
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Wound
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated w/radiation
|
36.4%
16/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
11.4%
5/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
AST, SGOT
|
9.1%
4/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
Alkaline phosphatase
|
11.4%
5/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
Creatinine
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
20.7%
6/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
Leukocytes (total WBC)
|
54.5%
24/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
45.5%
10/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
Lymphopenia
|
9.1%
4/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
13.6%
3/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
43.2%
19/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
45.5%
10/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
Platelets
|
31.8%
14/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
31.0%
9/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Investigations
Weight loss
|
25.0%
11/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
22.7%
5/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
15.9%
7/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.4%
5/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.9%
7/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
13.6%
3/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
9.1%
4/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
17.2%
5/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
18.2%
4/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
15.9%
7/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
6.8%
3/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
9.1%
4/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
22.7%
5/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Nervous system disorders
Neuropathy: sensory
|
20.5%
9/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
40.9%
9/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
27.3%
12/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
13.6%
3/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Psychiatric disorders
Mood alteration - depression
|
6.8%
3/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
3/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
31.8%
7/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
18.2%
4/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
20.7%
6/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
10.3%
3/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
6.8%
3/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
25.0%
11/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
13.6%
3/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
0.00%
0/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
|
Vascular disorders
Hypotension
|
11.4%
5/44 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
6.9%
2/29 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
9.1%
2/22 • Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
|
Additional Information
Lung Committee Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place