Clinical trial NCT01932580: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Adenocarcinoma
Esophageal Adenocarcinoma
Keywords: gastric
esophageal
adenocarcinoma
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Rate of severe gastrointestinal toxicity (grade 3-4) stomatitis or diarrhea) in the preoperative setting.
timeFrame: One year
Secondary outcomes:
measure: Improvement of dysphagia score
timeFrame: 1 and 2 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Thierry Alcindor, MD, MSc
role: STUDY_CHAIR
References: