Trial Outcomes & Findings for S0429: Docetaxel, Cetuximab, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer (NCT NCT00288054)
NCT ID: NCT00288054
Last Updated: 2013-01-04
Results Overview
The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.
Results posted on
2013-01-04
Participant Flow
Participant milestones
| Measure |
Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)
Eligible patients who began protocol treatment were included in the analysis.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)
Eligible patients who began protocol treatment were included in the analysis.
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Lack of Efficacy
|
16
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Not protocol specified
|
2
|
Baseline Characteristics
S0429: Docetaxel, Cetuximab, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)
n=22 Participants
Eligible patients who began protocol treatment were included in the analysis.
|
|---|---|
|
Age Continuous
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 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: Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.Population: Eligible patients who received protocol treatment were included in the analysis.
The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.
Outcome measures
| Measure |
Cetuximab + Chest Radiation Therapy
n=22 Participants
|
|---|---|
|
Treatment-related Esophagitis or Pneumonitis
|
5 percentage of participants
Interval 0.0 to 23.0
|
SECONDARY outcome
Timeframe: Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment.Population: Eligible patients who received protocol treatment.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Cetuximab + Chest Radiation Therapy
n=22 Participants
|
|---|---|
|
Toxicity
Pain - Head/headache
|
1 Participants
|
|
Toxicity
Allergic reaction/hypersensitivity
|
1 Participants
|
|
Toxicity
Ataxia (incoordination)
|
1 Participants
|
|
Toxicity
Burn
|
1 Participants
|
|
Toxicity
Cardiac troponin I (cTnI)
|
1 Participants
|
|
Toxicity
Cough
|
1 Participants
|
|
Toxicity
Dehydration
|
1 Participants
|
|
Toxicity
Diarrhea
|
1 Participants
|
|
Toxicity
Dyspnea (shortness of breath)
|
3 Participants
|
|
Toxicity
Esophagitis
|
1 Participants
|
|
Toxicity
Fatigue (asthenia, lethargy, malaise)
|
1 Participants
|
|
Toxicity
Hypoxia
|
1 Participants
|
|
Toxicity
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
1 Participants
|
|
Toxicity
Left ventricular diastolic dysfunction
|
1 Participants
|
|
Toxicity
Lymphopenia
|
4 Participants
|
|
Toxicity
Magnesium, serum-low (hypomagnesemia)
|
3 Participants
|
|
Toxicity
Muscle weakness, not d/t neuropathy - Extrem-lower
|
1 Participants
|
|
Toxicity
Neurology-Other (Specify)
|
1 Participants
|
|
Toxicity
Neutrophils/granulocytes (ANC/AGC)
|
1 Participants
|
|
Toxicity
Pain - Skin
|
1 Participants
|
|
Toxicity
Potassium, serum-low (hypokalemia)
|
1 Participants
|
|
Toxicity
Rash: acne/acneiform
|
2 Participants
|
|
Toxicity
Syncope (fainting)
|
1 Participants
|
|
Toxicity
Thrombosis/thrombus/embolism
|
1 Participants
|
SECONDARY outcome
Timeframe: weekly while patient is on protocol treatment, then monthly thereafter.Population: Eligible patients who began protocol treatment were included in the analysis.
The duration form the date of enrollment until the date of death due to any cause. Patients last known to be alive are censored at the date of last contact.
Outcome measures
| Measure |
Cetuximab + Chest Radiation Therapy
n=22 Participants
|
|---|---|
|
Overall Survival
|
14 months
Interval 8.0 to 24.0
|
SECONDARY outcome
Timeframe: At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment.Population: Eligible patients who began protocol treatment were included in the analysis.
Duration from the date of enrollment until the date of progression (as defined by RECIST: \>= 20% increase over baseline in the sum of longest diameters, or appearance of new lesions, or non-measurable disease that is clearly worsening in the opinion of the treating investigator, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and free of disease progression are censored at the date of last contact.
Outcome measures
| Measure |
Cetuximab + Chest Radiation Therapy
n=22 Participants
|
|---|---|
|
Progression-free Survival.
|
8 months
Interval 5.0 to 9.0
|
SECONDARY outcome
Timeframe: Week 10 and week 22Population: Eligible patients who began protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.
Confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease (as defined per RECIST). A confirmed complete response (CR) is defined as disappearance of all disease, confirmed by a second determination of CR at least 4 weeks later. A confirmed partial response (PR) is defined as a \>= 30% decrease from baseline in the sum of longest diameters, confirmed by a second determination of PR at least 4 weeks later. A patient is considered to have measurable disease if they have at least one lesion with a longest diameter of \>= 2 cm by conventional CT, or \>= 1 cm by spiral CT.
Outcome measures
| Measure |
Cetuximab + Chest Radiation Therapy
n=19 Participants
|
|---|---|
|
Response Rate
|
47 percentage of participants
Interval 24.0 to 71.0
|
Adverse Events
Cetuximab + Chest Radiation Therapy
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab + Chest Radiation Therapy
n=22 participants at risk
|
|---|---|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
4.5%
1/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
Cardiac troponin I (cTnI)
|
4.5%
1/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
4.5%
1/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
4.5%
1/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
4.5%
1/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.5%
1/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
Other adverse events
| Measure |
Cetuximab + Chest Radiation Therapy
n=22 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
36.4%
8/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
18.2%
4/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Eye disorders
Ocular/Visual-Other (Specify)
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Eye disorders
Vision-blurred vision
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
4/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
40.9%
9/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
45.5%
10/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
40.9%
9/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
22.7%
5/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Gastrointestinal disorders
Pain - Esophagus
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
General disorders
Constitutional Symptoms-Other (Specify)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
General disorders
Edema: limb
|
22.7%
5/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
68.2%
15/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
General disorders
Pain-Other (Specify)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
18.2%
4/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Infections and infestations
Infection-Other (Specify)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Infections and infestations
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Gr 3-4 thrombocytopenia)
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Injury, poisoning and procedural complications
Burn
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated w/Chemoradiation
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
AST, SGOT
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
Alkaline phosphatase
|
18.2%
4/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
Creatinine
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
INR (of prothrombin time)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
Leukocytes (total WBC)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
Lymphopenia
|
31.8%
7/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
Platelets
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
Weight gain
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Investigations
Weight loss
|
18.2%
4/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
27.3%
6/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
6/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
22.7%
5/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
36.4%
8/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
27.3%
6/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
27.3%
6/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - Extrem-lower
|
18.2%
4/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
18.2%
4/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Nervous system disorders
Dizziness
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Nervous system disorders
Neurology-Other (Specify)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Nervous system disorders
Neuropathy: sensory
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Nervous system disorders
Ocular/Visual-Other (Specify)
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Nervous system disorders
Pain - Head/headache
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Psychiatric disorders
Mood alteration - depression
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Renal and urinary disorders
Pain - Bladder
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.9%
9/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
45.5%
10/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
27.3%
6/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.2%
4/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pain - Skin
|
9.1%
2/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
18.2%
4/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
27.3%
6/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
68.2%
15/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Vascular disorders
Hypertension
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
|
Vascular disorders
Hypotension
|
13.6%
3/22 • Weekly for the first 8 weeks, then every 4 weeks while on protocol treatment.
|
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