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

October 25, 2015 updated by: Dr. Thierry Alcindor, McGill University

Pilot Study of Perioperative Docetaxel, Oxaliplatin, and 5-Fluorouracil (FLOT) in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Drug: FLOT (5-fluorouracil, oxaliplatin, docetaxel)
Administration of FLOT chemotherapy before and after surgery
Other Names:
  • Oxaliplatin: Eloxatin
  • Docetaxel: Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of severe gastrointestinal toxicity (grade 3-4) stomatitis or diarrhea) in the preoperative setting.
Time Frame: One year
Measurement through quality-of-life questionnaire
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of dysphagia score
Time Frame: 1 and 2 months
Measurement through dysphagia score
1 and 2 months

Collaborators and Investigators

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

Sponsor

McGill University

Investigators

  • Study Chair: Thierry Alcindor, MD, MSc, McGill University

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

August 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 25, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGH-TA-01 / McG 1319

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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