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Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach

NCT00601705 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2019-04-30

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, oxaliplatin, fluorouracil, 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. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy, surgery, and radiation therapy works in treating patients with locoregionally advanced cancer of the esophagus, gastroesophageal junction, or stomach.

Conditions

Interventions

DRUG

cisplatin

20 mg/m2/day IV continuous infusion over 24 hours for 96 total hours.

DRUG

epirubicin hydrochloride

50 mg/m2 IV bolus

DRUG

fluorouracil

200 mg/m2/day will be given as a continuous intravenous infusion for all 9 weeks, beginning on day 1.

DRUG

oxaliplatin

130 mg/m2 IV infusion over 2 hours

PROCEDURE

adjuvant therapy

Between 6-10 weeks after surgery patients will begin postoperative chemoradiotherapy. Daily radiation therapy fractions of 180-200 cGy will be given to the esophago-gastric bed and draining lymphatic regions to a total dose of 50-55 Gy (60 Gy in the event of an R1 or R2 resection). Concurrent with this radiation, two cycles of chemotherapy will be given, during the first and fourth weeks of the radiation

PROCEDURE

neoadjuvant therapy

Three weeks after discontinuing the fluorouracil (12 weeks after study entry) patients will be fully restaged to assess for a clinical response, and to ensure that there is no contraindication to surgical resection, which will be scheduled for approximately one week later (13 weeks after study entry). Surgery will consist of a transthoracic esophagogastrectomy or a total gastrectomy with Roux-en-Y esophagojejunostomy depending on the location and extent of the tumor at surgery. An appropriate lymphadenectomy will be performed. Immediate reconstruction is anticipated if possible.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • David J. Adelstein, MD · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-05
Primary Completion
2012-03-26
Completion
2015-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00601705 on ClinicalTrials.gov