Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021320 |
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Evaluation Of Paclitaxel, Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer |
Study Start Date: | May 2000 |
OBJECTIVES:
OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses.
Beginning 3 weeks after completion of initial chemotherapy, patients receive concurrent chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29; fluorouracil IV continuously for 5 weeks; and radiotherapy daily 5 days a week for 5 weeks.
At 4-8 weeks after completion of chemoradiotherapy, patients may undergo surgical resection. Patients with local progressive disease after 2 courses of initial chemotherapy undergo surgical resection instead of receiving concurrent chemoradiotherapy.
Patients are followed within 6 weeks, every 3 months for 3 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111-2497 |
Study Chair: | Jonathan Cheng, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000068769, FCCC-00003, NCI-G01-1982 |
Study First Received: | July 11, 2001 |
Last Updated: | October 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00021320 |
Health Authority: | United States: Federal Government |
stage 0 esophageal cancer stage I esophageal cancer stage II esophageal cancer |
stage III esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus |
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Squamous cell carcinoma Carcinoma Epidermoid carcinoma Digestive System Diseases Cisplatin |
Paclitaxel Fluorouracil Head and Neck Neoplasms Carcinoma, squamous cell Gastrointestinal Neoplasms Esophageal Diseases Carcinoma, Squamous Cell Adenocarcinoma Esophageal neoplasm |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |