The GYMSSA trial: a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone.
BACKGROUND
The standard of care for metastatic gastric cancer (MGC) is systemic chemotherapy which leads to a median survival of 6-15 months. Survival beyond 3 years is rare. For selected groups of patients with limited MGC, retrospective studies have shown improved overall survival following gastrectomy and metastasectomies including peritoneal stripping with continuous hyperthermic peritoneal perfusion (CHPP), liver resection, and pulmonary resection. Median survival after liver resection for MGC is up to 34 months, with a five year survival rate of 24.5%. Similarly, reported median survival after pulmonary resection of MGC is 21 months with long term survival of greater than 5 years a possibility. Several case reports and small studies have documented evidence of long-term survival in select individuals who undergo CHPP for MGC.


METHODS
The GYMSSA trial is a prospective randomized trial for patients with MGC. It is designed to compare two therapeutic approaches: gastrectomy with metastasectomy plus systemic chemotherapy (GYMS) versus systemic chemotherapy alone (SA). Systemic therapy will be composed of the FOLFOXIRI regimen. The aim of the study is to evaluate overall survival and potential selection criteria to determine those patients who may benefit from surgery plus systemic therapy. The study will be conducted by the Surgery Branch at the National Cancer Institute (NCI), National Institutes of Health (NIH) in Bethesda, Maryland. Surgeries and followup will be done at the NCI, and chemotherapy will be given by either the local oncologist or the medical oncology branch at NCI.


BACKGROUND
ClinicalTrials.gov ID. NCT00941655.
Kerkar
Sid P
SP
Surgery Branch, CCR, NCI, Bethesda, MD, USA. kerkars@mail.nih.gov
Kemp
Clinton D
CD
Duffy
Austin
A
Kammula
Udai S
US
Schrump
David S
DS
Kwong
King F
KF
Quezado
Martha
M
Goldspiel
Barry R
BR
Venkatesan
Aradhana
A
Berger
Ann
A
Walker
Melissa
M
Toomey
Mary Ann
MA
Steinberg
Seth M
SM
Giaccone
Guiseppe
G
Rosenberg
Steven A
SA
Avital
Itzhak
I
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000031:analogs & derivatives / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005472:Fluorouracil / Q000627:therapeutic use; D005743:Gastrectomy; D006498:Hepatectomy; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D002955:Leucovorin / Q000627:therapeutic use; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010537:Peritoneum / Q000601:surgery; D011013:Pneumonectomy; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000556:secondary / Q000601:surgery; D015996:Survival Rate
D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin