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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) North Central Cancer Treatment Group Radiation Therapy Oncology Group Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003118 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy and radiation therapy for cancer of the esophagus.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy and radiation therapy in treating patients who have cancer of the esophagus that can be surgically removed.
Condition | Intervention | Phase |
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Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Procedure: surgical procedure Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Prospective Randomized Phase III Trial Comparing Trimodality Therapy (Cisplatin, 5-FU, Radiotherapy, and Surgery) to Surgery Alone for Esophageal Cancer |
Estimated Enrollment: | 500 |
Study Start Date: | October 1997 |
OBJECTIVES: I. Compare overall five-year survival rates and treatment failures in patients receiving neoadjuvant cisplatin (CDDP) plus fluorouracil (5-FU) with concomitant radiotherapy followed by surgical resection versus patients receiving surgery alone. II. Assess and compare the toxicities of each approach. III. Compare the incidence and pattern of local (gastric or esophageal bed or regional lymph nodes) and distant (supraclavicular lymph node, liver, peritoneal carcinomatosis, or lung, brain, etc.) recurrence. IV. Evaluate the prognostic ability of noninvasive and minimally invasive pretreatment staging with regard to survival and recurrence. V.
Evaluate the ability of preresection adjuvant chemotherapy with concomitant radiation therapy to render tumors to lower stages. VI. Evaluate the impact of lymph nodes on survival and recurrence.
OUTLINE: This a two arm, randomized study. Patients are stratified by: cell type of cancer (squamous cell vs adenocarcinoma); lymph nodes (positive vs negative); and stage (invasive vs noninvasive). Patients in arm I undergo chemotherapy and radiotherapy within 24 hours of each other. Chemotherapy consists of cisplatin (CDDP) by bolus IV infusion over 30 minutes on day 1 and again on day 29. Fluorouracil (5-FU) is administered by continuous IV infusion for 4 days (on days 1-4 and 29-32) after completion of cisplatin. Radiotherapy is administered on days 1-5, 8-12, 15-19, 22-26, and 29-33, with a boost on days 36-38. If there is no disease progression or unresectable disease, surgery is performed within 3-8 weeks following completion of therapy. Patients in arm II undergo surgery alone no later than 6 weeks postrandomization. Patients are followed at least every 3 months for two years, then every 6 months for the next two years, and annually thereafter.
PROJECTED ACCRUAL: There will be 500 patients accrued into this study within 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus or gastroesophageal junction Stages I, IIA, IIB, or III Tumor must be considered surgically resectable No positive supraclavicular nodes (greater than 1.5 cm by CT) or palpable supraclavicular nodes No positive (greater than 1.5 cm by CT) nodes in levels 15-20 Lymph node involvement in levels 15, 16, and 20 that are no greater than 1.5 cm by CT allowed Patient without radiographical evidence of lymph node involvement in levels 15, 16, and 20 that are proven positive at time of presurgical staging also allowed Radiographically positive lymph node involvement in levels 17-19 allowed only if proven to be negative by biopsy No positive lymph node involvement in levels 17-19 even if there was no radiographic evidence of lymph node involvement No tumors with greater than 2 cm distal spread into the gastric cardia No distant metastases (suspicious lesions on CT should be tested by ultrasound, MRI or biopsy)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,800/mm3 Platelet count at least 100,000/mm3 Hepatic: If alkaline phosphatase is greater than 3 times normal, must undergo esophagoscopy with biopsy, barium esophagogram, CT scan of the chest and upper abdomen, and bone scan Renal: Creatinine clearance at least 50 mL/min Other: No other prior malignancy unless disease free for greater than 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this malignancy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy that would overlap the field(s) treated in this study Surgery: Not specified
Study Chair: | Mark J. Krasna, MD | University of Maryland Greenebaum Cancer Center |
Study Chair: | Richard M. Goldberg, MD | Mayo Clinic |
Study Chair: | Tyvin A. Rich, MD | University of Virginia |
Study Chair: | Richard H. Feins, MD | James P. Wilmot Cancer Center |
Study ID Numbers: | CDR0000065873, CLB-C9781, E-C9781, NCCTG-C9781, RTOG-9716 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003118 History of Changes |
Health Authority: | United States: Federal Government |
stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus |
Antimetabolites Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Squamous Cell Carcinoma Immunosuppressive Agents Carcinoma Digestive System Diseases |
Radiation-Sensitizing Agents Cisplatin Esophageal Disorder Fluorouracil Head and Neck Neoplasms Epidermoid Carcinoma Gastrointestinal Neoplasms Esophageal Diseases Carcinoma, Squamous Cell Adenocarcinoma |
Antimetabolites Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Digestive System Diseases Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Head and Neck Neoplasms Fluorouracil Therapeutic Uses Gastrointestinal Neoplasms Esophageal Diseases |