Pilot Study of Perioperative Docetaxel, Oxaliplatin, and 5-Fluorouracil (FLOT) in Gastroesophageal Adenocarcinoma

NCT ID: NCT01932580

Last Updated: 2015-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-06-30

Brief Summary

Gastric or gastroesophageal junction adenocarcinoma is commonly treated with chemotherapy before and after surgery. The chemotherapy regimen used in our institution, called DCF (docetaxel,cisplatic, 5-fluorouracil) is active, resulting in tumor reduction and dysphagia relief. however, it is toxic, causing approximately half of patients severe inflammation of the mucosa (lining) of the mouth and gut. This results, in turn, in mouth sores, vomiting and diarrhea. Similar regimen called FLOT (5-FU, oxaliplatin,docetaxel) appears to be at least equally active, but less toxic.

Our ultimate plan is to perform a randomized comparison of DCF and FLOT. Before embarking upon this, we are conducting this pilot trial in 10 subjects with the FLOT regimen. If less than 5 patients develop severe mouth sores, vomiting or diarrhea, plans will be made to proceed with the next trial, a randomized comparison of DCF and FLOT

Detailed Description

Data about occurrence of diarrhea and mouth sores will be recorded through the use of quality-of-life questionnaires

Conditions

Gastric Adenocarcinoma; Esophageal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FLOT chemotherapy

Chemotherapy to be administered every 2 weeks for 4 cycles, before surgery. Then 4 more cycles will be given after surgery, at 2-week intervals.

5-FU 2600 mg IV/m2 in continuous infusion Leucovorin 200 mg IV/m2 Oxaliplatin 85 mg IV/m2 Docetaxel 50 mg IV/m2

Group Type: OTHER

FLOT (5-fluorouracil, oxaliplatin, docetaxel)

Intervention Type: DRUG

Administration of FLOT chemotherapy before and after surgery

Interventions

FLOT (5-fluorouracil, oxaliplatin, docetaxel)

Administration of FLOT chemotherapy before and after surgery

Intervention Type: DRUG

Other Intervention Names

Oxaliplatin: Eloxatin; Docetaxel: Taxotere

Eligibility Criteria

Inclusion Criteria

• Histological diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction (GEJ), or lower third of the esophagus.
• The tumor must be deemed by the team to be potentially resectable. This includes imaging studies (detailed below) to clinically stage the tumor and rule out the presence of metastatic disease, and includes a preoperative laparoscopic evaluation.
• Stage IB (T1N1 only), II, IIIA, IIIB, and IV (T4N1 only)
• Life expectancy greater than 3 months
• ECOG performance status of 0-2 (i.e. restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work).
• Adequate hematologic reserve: Platelet count greater than or equal to 100,000 microlitre, WBC greater than or equal to 2000 microlitre,
• Creatinine clearance greater than or equal to 30 ml/min, AST & ALT less than or equal to 2 ULN, Alkaline phosphatase less than or equal to 2.5 ULN, bilirubin less than or equal ULN

Exclusion Criteria

• Prior systemic therapy for gastric cancer
• Prior docetaxel-containing chemotherapy
• Pre-existing medical conditions precluding treatment, including any contraindication for major surgery
• Pregnancy or lactating mothers. Women of childbearing age must use contraception during and for 3 months following treatment
• Inability to give informed consent
• Inability to maintain nutrition by oral consumption of food alone must have additional enteral feeding.
• Macroscopic disease noted at laparoscopy
• ECOG peformance status of 3 or higher
• Unwillingness to undergo investigations and/or treatment as outlined on the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Thierry Alcindor

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thierry Alcindor, MD, MSc

Role: STUDY_CHAIR

McGill University

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

MGH-TA-01 / McG 1319

Identifier Type: -

Identifier Source: org_study_id