Prospective Randomized Trial Comparing Gastrectomy, Metastasectomy Plus Systemic Therapy Versus Systemic Therapy Alone: GYMSSA Trial

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00941655
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Oxaliplatin 85 mg/m\^2 over 120 minutes,
  • Irinotecan — DRUG
    Irinotecan 165 mg/m\^2 IV over 90 minutes
  • 5-Fluorouracil — DRUG
    Surgery and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. systemic chemotherapy -3200 mg/m\^2 continuous intravenous over 48 hours.
  • Leucovorin — DRUG
    surgery and heated intraperitoneal chemotherapy -20 mg/m\^2 intravenous over 5 minutes. systemic chemotherapy - 200 mg/m\^2 intravenous over 120 minutes.
  • Gastrectomy and/or metastasectomy — PROCEDURE
    Gastrectomy: tumor resection and a bypass; palliative treatment for pain, bleeding, obstruction and/or if deemed in the best interest of the patient. Metastasectomy: anatomical segmental resection to render the patient no evidence of disease (NED) with at least 1cm negative margins when possible, followed by systemic chemotherapy.

Study Details

Background: * Gastric (stomach) cancer is a rare cancer. In most cases, by the time it has been diagnosed it has spread to other organs in the body and the chance of a cure is very small. The standard treatment for gastric cancer is a combination of chemotherapy drugs. * Researchers are interested in finding out if surgically removing all tumors before beginning chemotherapy for stomach cancer can slow or halt its spread better than giving chemotherapy alone. Objectives: \- To determine whether tumor removal surgery followed by chemotherapy is more effective in treating gastric cancer than chemotherapy given alone. Eligibility: \- Patients 18 years of age and older who have been diagnosed with gastric cancer. Design: * All patients will undergo an initial physical examination, blood tests, imaging scans, and a laparoscopy to determine the extent of the disease. * Half of the participants will be assigned to have surgery first and then chemotherapy; the other half will be assigned to have chemotherapy alone. * The surgery-plus-chemotherapy group will have major surgery to remove all tumors in the stomach and abdominal area, followed by a recovery time of up to 4 weeks. Chemotherapy will begin 6 to 8 weeks after surgery. * The chemotherapy-only group will begin treatment within 2 weeks of laparoscopy. * All patients will receive four chemotherapy drugs: 5-Fluorouracil, leucovorin, oxaliplatin, and irinotecan. The drugs are given intravenously over 2 days every 2 weeks (one cycle) for 12 cycles (about 6 months), either at the National Institutes of Health (NIH) Clinical Center or at home with a referring oncologist. Patients in the surgery group who have tumors in the peritoneum will receive an additional set of chemotherapy drugs in a separate treatment. * During the chemotherapy cycles, patients will provide blood samples approximately once a week and will have physical examinations and scans on a regular basis. * Patients will return to the NIH Clinical Center for follow-up visits about every 4 months for 2 years, then every 6 months for 3 years and yearly thereafter.

Key Dates

Start date
Jul 22, 2009
Status verified
Nov 2019
Primary completion
Jul 14, 2011
Completion
Jun 18, 2012

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Surgery + HIPEC + Systemic Chemotherapy
    Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
  • Experimental: Systemic Chemotherapy Alone
    Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.

Primary Outcome Measure

Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I [ Time Frame: 12 weeks up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

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