ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01932580
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Thierry Alcindor, McGill University

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


Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Esophageal Adenocarcinoma Drug: FLOT (5-fluorouracil, oxaliplatin, docetaxel) Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Perioperative Docetaxel, Oxaliplatin, and 5-Fluorouracil (FLOT) in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Study Start Date : August 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Improvement of dysphagia score [ Time Frame: 1 and 2 months ]
    Measurement through dysphagia score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932580


Locations
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University
Investigators
Study Chair: Thierry Alcindor, MD, MSc McGill University

Additional Information:
Responsible Party: Dr. Thierry Alcindor, MD, McGill University
ClinicalTrials.gov Identifier: NCT01932580     History of Changes
Other Study ID Numbers: MGH-TA-01 / McG 1319
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Dr. Thierry Alcindor, McGill University:
gastric
esophageal
adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs