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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) North Central Cancer Treatment Group Cancer and Leukemia Group B |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00533949 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Radiation Toxicity |
Biological: cetuximab Drug: carboplatin Drug: paclitaxel Radiation: 3-dimensional conformal radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 500 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients undergo standard-dose radiotherapy 5 days a week for 6 weeks. Patients receive concurrent chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients also receive consolidation treatment of paclitaxel and carboplatin. Treatment repeats in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV over 30 minutes
Drug: paclitaxel
Given IV over 1 hour (arm II closed to accrual effective 6/17/11)
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiation therapy 5 days a week (arm II closed to accrual effective 6/17/11)
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Experimental: Arm II
Patients undergo high-dose radiotherapy 5 days per week for 7.5 weeks. Patient also receive concurrent paclitaxel and carboplatin and receive consolidation treatment as in Arm I on days 1, 8, 15, 22, 29, 36 and 43. (closed to accrual effective 6/17/11)
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Drug: carboplatin
Given IV over 30 minutes
Drug: paclitaxel
Given IV over 1 hour (arm II closed to accrual effective 6/17/11)
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiation therapy 5 days a week (arm II closed to accrual effective 6/17/11)
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Experimental: Arm III
Patients undergo standard-dose radiotherapy as in Arm I. Patients receive cetuximab and receive concurrent chemotherapy and consolidation treatment comprising cetuximab, paclitaxel, and carboplatin periodically for up to 16 weeks.
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Biological: cetuximab
Given IV (arm IV closed to accrual effective 6/17/11)
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Experimental: Arm IV
Patients undergo high-dose radiotherapy as in arm II and receive concurrent cetuximab, concurrent chemotherapy, and consolidation treatment as in Arm III. (closed to accrual effective 6/17/11)
|
Biological: cetuximab
Given IV (arm IV closed to accrual effective 6/17/11)
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer (NSCLC)
Stage IIIA or IIIB disease
Pleural effusion allowed provided effusion is minimal and none of the following conditions are present:
PATIENT CHARACTERISTICS:
No severe, active comorbidity, including any of the following:
No significant history of uncontrolled cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 213 Study Locations| Principal Investigator: | Jeffrey Bradley, MD | Mallinckrodt Institute of Radiology at Washington University Medical Center |
| Investigator: | Hak Choy, MD | Simmons Cancer Center |
| Investigator: | Gregory A. Masters, MD | CCOP - Christiana Care Health Services |
| Study Chair: | Steven E. Schild, MD | Mayo Clinic |
| Investigator: | Alex A. Adjei, MD, PhD | Roswell Park Cancer Institute |
| Study Chair: | Jeffrey A. Bogart, MD | State University of New York - Upstate Medical University |
| Investigator: | Arthur William Blackstock, MD | Comprehensive Cancer Center of Wake Forest University |
| Investigator: | Mark A. Socinski, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00533949 History of Changes |
| Other Study ID Numbers: | CDR0000564240, RTOG-0617, NCCTG-N0628, CALGB-30609 |
| Study First Received: | September 20, 2007 |
| Last Updated: | November 24, 2011 |
| Health Authority: | United States: Federal Government |
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radiation toxicity stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
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Carcinoma, Non-Small-Cell Lung Lung Neoplasms Radiation Injuries Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Wounds and Injuries |
Cetuximab Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |