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| Sponsored by: |
European Institute of Oncology |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002897 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether chemotherapy before surgery is more effective than surgery alone in treating cancer of the esophagus.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus.
| Condition | Intervention | Phase |
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Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery |
Phase III |
| MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders |
| ChemIDplus related topics: | Cisplatin Fluorouracil |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER |
| Estimated Enrollment: | 240 |
| Study Start Date: | July 1992 |
OBJECTIVES: I. Compare resectability and survival in patients with stage II/III esophageal cancer treated with neoadjuvant cisplatin/fluorouracil vs. surgery alone.
OUTLINE: This is a randomized study. Patients are randomized to one of two groups. The first group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by esophagectomy and regional lymphadenectomy. The second group undergoes esophagectomy and regional lymphadenectomy alone. All patients are followed for survival.
PROJECTED ACCRUAL: A total of 240 patients will be entered over 4 years.
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed esophageal squamous cell cancer that is stage T2-3 Nx M0
PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5 years except: Basal cell skin carcinoma Carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Contacts and Locations More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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Ancona E, Ruol A, Santi S, Merigliano S, Sileni VC, Koussis H, Zaninotto G, Bonavina L, Peracchia A. Only pathologic complete response to neoadjuvant chemotherapy improves significantly the long term survival of patients with resectable esophageal squamous cell carcinoma: final report of a randomized, controlled trial of preoperative chemotherapy versus surgery alone. Cancer. 2001 Jun 1;91(11):2165-74.
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Ancona E, Ruol A, Santi S, et al.: Major response to neoadjuvant chemotherapy leads to improved long-term survival in potentially resectable (T2-3, any N, M0) esophageal squamous cell carcinoma. Final report of a randomized trial of neoadjuvant chemotherapy versus surgery alone. [Abstract] Proceedings of the European Surgical Association 7th annual meeting, Amsterdam, April 14-15, 2000.
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| Study ID Numbers: | CDR0000065226, CNR-012809, EU-96038 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002897 |
| Health Authority: | United States: Federal Government |
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