A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)
carboplatin
+ paclitaxel
+ radiation therapy
Adenocarcinoma+13
+ Bronchial Neoplasms
+ Carcinoma
Treatment Study
Summary
Study start date: January 1, 2000
Actual date on which the first participant was enrolled.OBJECTIVES: I. Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy with or without thalidomide. II. Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups. III. Determine whether the inactivation of p16, Death-associated protein kinase (DAP-kinase), O6-methylguanine-DNA methyltransferase (MGMT) gene, or tissue-inhibitor of metalloproteinase 3 (TIMP-3) genes can be used to predict survival in these patients treated with this regimen. IV. Determine whether the detection of a methylation biomarker in serum can be used to predict survival in these patients treated with this regimen. OUTLINE: This is a randomized study. Patients are stratified according to disease histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and time of randomization (before addition of chemoradiotherapy vs after). Patients are randomized to one of two treatment arms. ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours immediately followed by carboplatin IV over 15-30 minutes on days 1 and 22. Treatment continues every 22 days in the absence of unacceptable toxicity or disease progression. ARM B: Patients receive paclitaxel and carboplatin as in arm A. Patients also receive oral thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the absence of disease progression. Beginning between days 43-50, patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy (RT) 5 days a week for 6 weeks. Arm B patients continue oral thalidomide. Patients are followed every 2 months for 2 years and then every 6 months for 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.589 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma Squamous cell Adenocarcinoma Large cell undifferentiated Bronchoalveolar Non-small cell carcinoma not otherwise stated Unresectable stage IIIA Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule out resectability OR Stage IIIB disease without significant pleural effusion Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative Metastases to contralateral, mediastinal, or supraclavicular nodes allowed Bidimensionally measurable or evaluable disease 18 and over ECOG performance status 0-1 Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to registration: Platelet count at least 100,000/mm^3 White Blood Cell (WBC) count at least 4,000/mm^3 OR absolute neutrophil count at least 2,000/mm^3 Bilirubin normal Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper limit of normal Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy Concurrent filgrastim (G-CSF) allowed for persistent neutropenia Exclusion Criteria: Positive pregnancy test,pregnant or nursing Uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year Serious cardiac arrhythmias requiring medication Prior radiotherapy to only area of measurable or active tumor Less than 5 years since prior chemotherapy Other active malignancies Serious uncontrolled active infection Evidence of greater than grade 1 neuropathy by history or physical examination History of seizure disorders Contraindication to daily low-dose (81 mg/day) aspirin
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 236 locations
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, United StatesOpen Hembree Mercy Cancer Center at St. Edward Mercy Medical Center in Google MapsMemorial Medical Center Cancer Services
Modesto, United StatesSalinas Valley Memorial Hospital
Salinas, United StatesStanford Comprehensive Cancer Center at Stanford University Medical Center
Stanford, United States