Prospective Randomized Trial Comparing Gastrectomy, Metastasectomy Plus Systemic Therapy Versus Systemic Therapy Alone: GYMSSA Trial
- The standard of care for metastatic gastric cancer (MGC) is systemic therapy resulting
in median survival of 6-12 months and rare survivors of up to three years.
- For patients with limited MGC, retrospective studies have shown improved overall
survival following gastrectomy and/or metastasectomy plus systemic therapy (e.g. median
survival after liver resection for metastatic gastric cancer of 15-37 months, with a
five year survival rate of 25%).
- This prospective randomized trial for patients with MGC and limited metastases is
designed to compare two therapeutic approaches-gastrectomy with metastasectomy plus
systemic therapy (GYMS) vs. systemic therapy alone (SA)-- and to evaluate outcome in
light of selection criteria to define those patients who may benefit from the more
- To compare two therapeutic approaches--GYMS vs. SA--in terms of overall survival in
patients with limited MGC.
- To analyze selection criteria for patients who might benefit from the GYMS approach.
- To determine progression-free survival in both arms.
- MGC with limited metastatic disease thought to be resectable to no evidence of disease.
- 18 years old or greater with an ECOG 0-2
- Laboratory and physical examination parameters within acceptable limits by standard of
practice guidelines prior to surgery
- Patients will be randomized to receive gastrectomy and metastasectomy followed by
systemic chemotherapy (GYMS) or systemic chemotherapy (SA) alone and will be stratified
based on sites of metastatic disease, previous therapy and disease free interval.
- Patients in both arms will receive the FOLFOXIRI regimen (5-FU, leucovorin, oxaliplatin
- No cross over will be allowed.
- Survival analysis will be done in intention to treat fashion from time of
- Based on estimated 12 and 20 months overall survival for the SA and the GYMS arms
respectively, 68 patients per arm (power=0.80, 0.05 two-tailed log-rank test) will be
enrolled. Patients will be recruited over 6 years and followed for an additional 2
years from the date of entry of the last patient.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare two therapeutic approaches-gastrectomy and/or metastasectomy followed by systemic chemotherapy vs. systemic chemotherapy-alone in terms of overall survival in patients with limited metastatic gastric carcinoma.
Udo Rudloff, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|