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

NCT01932580 | Completed Phase 2

• 1 other identifier: MGH-TA-01 / McG 1319
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Adenocarcinoma; Esophageal Adenocarcinoma

Keywords

gastric; esophageal; adenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

  Measurement through quality-of-life questionnaire

  One year

Secondary Outcomes (1)

• Improvement of dysphagia score

  1 and 2 months

Study Arms (1)

FLOT chemotherapy

OTHER

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)

Interventions

FLOT (5-fluorouracil, oxaliplatin, docetaxel) DRUG

Administration of FLOT chemotherapy before and after surgery

Also known as: Oxaliplatin: Eloxatin, Docetaxel: Taxotere

FLOT chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Adenocarcinoma

Interventions

Fluorouracil; Oxaliplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Thierry Alcindor, MD, MSc

  McGill University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 30, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

CA (1)