Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus

February 19, 2021 updated by: UNICANCER

A PROSPECTIVE RANDOMISED TRIAL OF INDUCTION CHEMOTHERAPY WITH 5-FU CONTINUOUS IV INFUSION AND CISPLATIN VERSUS SURGERY IN RESECTABLE ADENOCARCINOMA OF THE LOW THIRD OF THE ESOPHAGUS AND CARDIOESOPHAGEAL JUNCTION

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 combining chemotherapy with surgery is more effective than surgery alone.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare survival in patients with operable adenocarcinoma of the lower third of the esophagus or the cardia treated with fluorouracil/cisplatin vs. no chemotherapy prior to surgical resection.
  • Assess whether neoadjuvant fluorouracil/cisplatin increases tumor resectability.

OUTLINE: This study is randomized for neoadjuvant chemotherapy. Patients are stratified by performance status, tumor location, and randomizing center.

Patients randomized to no neoadjuvant chemotherapy undergo resection of the tumor with adequate margins and resection of regional lymph nodes (R2 with at least 8 nodal groups recommended).

Patients randomized to neoadjuvant chemotherapy receive fluorouracil and cisplatin at 3-4 week intervals; fluorouracil is given by continuous intravenous infusion for 5 days and cisplatin is given on the first 2 days of fluorouracil administration. Tumor response is assessed after 2 courses; responding patients with no serious toxicity receive a third course. Surgery, as above, is initiated 4-6 weeks after the second or third course of chemotherapy. Upon recovery (within 3-6 weeks), patients who responded to neoadjuvant chemotherapy receive 3-4 additional courses of postoperative chemotherapy (maximum total of 6 courses). Patients whose best response was stable disease are assessed for postoperative radiotherapy.

Patients on either arm with positive resection margins, positive lymph nodes, or equivocal complete resection are referred for postoperative radiotherapy. Further therapy for patients with incomplete resection is at the discretion of the physician.

Patients are followed every 3-4 months for at least 5 years.

PROJECTED ACCRUAL: A total of 250 patients will be entered.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Adenocarcinoma of the lower third of the esophagus or the cardia for which complete resection is feasible

    • Extension to the cardia allowed

    • Cancer of the cardia with extension to the esophagus or stomach allowed

      • No in situ cancer of the cardia
    • No distant metastases

PATIENT CHARACTERISTICS:

Age:

  • Not over 75

Performance status:

  • WHO 0 or 1

Hematopoietic:

  • WBC at least 4,000
  • Polymorphonuclear lymphocytes greater than 2,000
  • Platelets at least 100,000

Hepatic:

  • Not specified

Renal:

  • Creatinine less than 1.3 mg/dL (120 micromoles/L)

Cardiovascular:

  • No prior myocardial infarction
  • No other cardiac contraindication to surgery

Pulmonary:

  • No respiratory contraindication to surgery

Other:

  • No second malignancy except:
  • Basal cell carcinoma of the skin
  • Adequately treated in situ carcinoma of the uterine cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for tumors of the cardia

Endocrine therapy

  • No prior radiotherapy for tumors of the cardia

Radiotherapy

  • Not specified

Surgery

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Marc Ychou, MD, PhD, Institut du Cancer de Montpellier - Val d'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Boige V, Pignon J, Saint-Aubert B, et al.: Final results of a randomized trial comparing preoperative 5-fluorouracil (F)/cisplatin (P) to surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC ACCORD07-FFCD 9703 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4510, 200s, 2007.
  • Ychou M, Pignon JP, Lasser P, et al.: Phase III preliminary results of preoperative fluorouracil (F) and cisplatin (P) versus surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC 94012-FFCD 9703 trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-4026, 2006.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 1996

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065190
  • FRE-FNCLCC-94012
  • EU-96018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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