NCT00601705

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

A Phase II Trial of Induction Chemotherapy With Epirubicin, Oxaliplatin and Fluorouracil (EOF) Followed by Esophagogastrectomy and Post-operative Concurrent Chemoradiotherapy With Fluorouracil and Cisplatin, in Patients With Loco-regionally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction and Gastric Cardia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * To assess the feasibility and tolerability of induction chemotherapy comprising epirubicin hydrochloride, oxaliplatin, and fluorouracil (EOF), followed by surgical resection and postoperative concurrent chemoradiotherapy comprising fluorouracil and cisplatin in patients with locoregionally advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia. Secondary * To determine the rate of complete and partial response to three courses of EOF induction chemotherapy. * To compare the recurrence-free and overall survival of patients treated with this regimen vs historical controls at this institution. * To compare patterns of failure in patients treated with this regimen vs historical controls at this institution. OUTLINE: * Induction chemotherapy: Patients receive epirubicin hydrochloride IV over 3-15 minutes and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. * Surgery: Four weeks after completion of induction chemotherapy, patients with locoregionally confined disease (T0-4, N0-1, M0-1a) undergo transthoracic esophagogastrectomy or total gastrectomy with Roux-en-Y esophagojejunostomy, depending on the location and extent of the tumor at the time of surgery. * Postoperative chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo radiotherapy 5 days a week for approximately 6 weeks. Patients also receive fluorouracil IV continuously and cisplatin IV continuously over 96 hours in weeks 1 and 4 of radiotherapy. After completion of study treatment, patients are followed every 8-12 weeks for 3 years.

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-01-05
• Primary completion: 2012-03-26
• Completion: 2015-01-23
• First posted: 2008-01-28
• Last updated: 2019-04-30
• Results posted: 2019-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study