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

Primary Purpose

Gastric Adenocarcinoma, Esophageal Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

FLOT (5-fluorouracil, oxaliplatin, docetaxel)

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring gastric, esophageal, adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Montreal General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FLOT chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of severe gastrointestinal toxicity (grade 3-4) stomatitis or diarrhea) in the preoperative setting.

Measurement through quality-of-life questionnaire

Secondary Outcome Measures

Improvement of dysphagia score

Measurement through dysphagia score

Full Information

NCT ID

NCT01932580

First Posted

August 23, 2013

Last Updated

October 25, 2015

Sponsor

McGill University

1. Study Identification

Unique Protocol Identification Number

NCT01932580

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McGill University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Adenocarcinoma, Esophageal Adenocarcinoma

Keywords

gastric, esophageal, adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FLOT chemotherapy

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

FLOT (5-fluorouracil, oxaliplatin, docetaxel)

Other Intervention Name(s)

Oxaliplatin: Eloxatin, Docetaxel: Taxotere

Intervention Description

Administration of FLOT chemotherapy before and after surgery

Primary Outcome Measure Information:

Title

Rate of severe gastrointestinal toxicity (grade 3-4) stomatitis or diarrhea) in the preoperative setting.

Description

Measurement through quality-of-life questionnaire

Time Frame

One year

Secondary Outcome Measure Information:

Title

Improvement of dysphagia score

Description

Measurement through dysphagia score

Time Frame

1 and 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thierry Alcindor, MD, MSc

Organizational Affiliation

McGill University

Official's Role

Study Chair

Facility Information:

Facility Name

Montreal General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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