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

Gastric Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932580
• Other study ID #: MGH-TA-01 / McG 1319
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2013
• Last updated: October 25, 2015
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Adenocarcinoma
• Esophageal Neoplasms
• Gastric Adenocarcinoma

Intervention

Drug:
• FLOT (5-fluorouracil, oxaliplatin, docetaxel)
Administration of FLOT chemotherapy before and after surgery

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of severe gastrointestinal toxicity (grade 3-4) stomatitis or diarrhea) in the preoperative setting.	Measurement through quality-of-life questionnaire	One year	Yes
Secondary	Improvement of dysphagia score	Measurement through dysphagia score	1 and 2 months	No

External Links

•   The Gerald Bronfman Center for Clinical Research in Oncology