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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00655876 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer.
PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.
Condition | Intervention | Phase |
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Esophageal Cancer |
Drug: cetuximab Drug: cisplatin Drug: paclitaxel Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery |
Estimated Enrollment: | 420 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo radiotherapy once daily, 5 days a week, for 5½ weeks.
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Drug: cetuximab
Given IV
Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV
Procedure: radiation therapy
Given 5 days a week for 5½ weeks
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Arm II: Active Comparator
Patients receive paclitaxel and cisplatin as in arm I. Patients also undergo radiotherapy as in arm I.
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Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV
Procedure: radiation therapy
Given 5 days a week for 5½ weeks
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to histology (adenocarcinoma vs squamous), cancer lesion size (< 5 cm vs ≥ 5cm), and disease status of celiac nodes (present vs absent). Patients are randomized to 1 of 2 treatment arms.
Patients undergo endoscopy 6 to 8 weeks after completion of chemoradiotherapy. Quality of life is assessed at baseline, within 1 week of post-treatment endoscopy, and at 1 and 2 years from beginning of study treatment.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction
No evidence of tracheoesophageal fistulas or invasion into the trachea or major bronchi
PATIENT CHARACTERISTICS:
No severe, active comorbidity, including any of the following:
Acquired immune deficiency syndrome based upon current CDC definition
PRIOR CONCURRENT THERAPY:
Study Chair: | Mohan Suntharalingam, MD | University of Maryland Greenebaum Cancer Center |
Investigator: | David H. Ilson, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000538085, RTOG-0436 |
Study First Received: | April 9, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00655876 |
Health Authority: | Unspecified |
stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus |
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Squamous cell carcinoma Cetuximab Carcinoma Epidermoid carcinoma Digestive System Diseases |
Cisplatin Paclitaxel Head and Neck Neoplasms Carcinoma, squamous cell Gastrointestinal Neoplasms Esophageal Diseases Carcinoma, Squamous Cell Adenocarcinoma Esophageal neoplasm |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Physiological Effects of Drugs Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |