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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00533949 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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.
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. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying high-dose radiation therapy given together with cetuximab and chemotherapy to see how well it works compared with standard-dose radiation therapy and chemotherapy in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Lung Cancer |
Biological: cetuximab Drug: carboplatin Drug: paclitaxel Radiation: 3-dimensional conformal radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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 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 |
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Arm I: Active Comparator
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, 35 and 42. Patients also receive consolidation treatment of paclitaxel and carboplatin. Treatment repeats in the absence of disease progression or unacceptable toxicity. |
Drug: carboplatin
Given IV over 30 minutes
Drug: paclitaxel
Given IV over 1 hour
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiation therapy 5 days a week
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Arm II: Experimental
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.
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Drug: carboplatin
Given IV over 30 minutes
Drug: paclitaxel
Given IV over 1 hour
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiation therapy 5 days a week
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Arm III: Experimental
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
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Arm IV: Experimental
Patients undergo high-dose radiotherapy as in arb II and receive concurrent cetuximab, concurrent chemotherapy, and consolidation treatment as in Arm III.
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Biological: cetuximab
Given IV
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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:
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 Scottsdale |
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 | Wake Forest University |
Investigator: | Mark A. Socinski, MD | UNC Lineberger Comprehensive Cancer Center |
Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
Study ID Numbers: | CDR0000564240, RTOG-0617, NCCTG-N0628, CALGB-30609 |
Study First Received: | September 20, 2007 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00533949 History of Changes |
Health Authority: | Unspecified |
radiation toxicity stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Cetuximab Carboplatin Antimitotic Agents Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |