The GYMSSA trial: a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone.

Sid P. Kerkar, Clinton D. Kemp, Austin Duffy, Udai S. Kammula, David S. Schrump, King F. Kwong, Martha Quezado, Barry R. Goldspiel, Aradhana Venkatesan, Ann Berger, Melissa Walker, Mary Ann Toomey, Seth M. Steinberg, Guiseppe Giaccone, Steven A. Rosenberg, Itzhak Avital

Research output: Contribution to journalArticle

Abstract

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. DESIGN: 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. TRIAL REGISTRATION: ClinicalTrials.gov ID. NCT00941655.

Original languageEnglish (US)
Pages (from-to)121
Number of pages1
JournalTrials
Volume10
DOIs
StatePublished - 2009
Externally publishedYes

Fingerprint

Metastasectomy
Gastrectomy
Stomach Neoplasms
Survival
National Cancer Institute (U.S.)
Drug Therapy
Therapeutics
Perfusion
Lung
Medical Oncology
Liver
National Institutes of Health (U.S.)
Standard of Care
Patient Selection
Survival Rate
Retrospective Studies

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

The GYMSSA trial : a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone. / Kerkar, Sid P.; Kemp, Clinton D.; Duffy, Austin; Kammula, Udai S.; Schrump, David S.; Kwong, King F.; Quezado, Martha; Goldspiel, Barry R.; Venkatesan, Aradhana; Berger, Ann; Walker, Melissa; Toomey, Mary Ann; Steinberg, Seth M.; Giaccone, Guiseppe; Rosenberg, Steven A.; Avital, Itzhak.

In: Trials, Vol. 10, 2009, p. 121.

Research output: Contribution to journalArticle

Kerkar, SP, Kemp, CD, Duffy, A, Kammula, US, Schrump, DS, Kwong, KF, Quezado, M, Goldspiel, BR, Venkatesan, A, Berger, A, Walker, M, Toomey, MA, Steinberg, SM, Giaccone, G, Rosenberg, SA & Avital, I 2009, 'The GYMSSA trial: a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone.', Trials, vol. 10, pp. 121. https://doi.org/10.1186/1745-6215-10-121
Kerkar, Sid P. ; Kemp, Clinton D. ; Duffy, Austin ; Kammula, Udai S. ; Schrump, David S. ; Kwong, King F. ; Quezado, Martha ; Goldspiel, Barry R. ; Venkatesan, Aradhana ; Berger, Ann ; Walker, Melissa ; Toomey, Mary Ann ; Steinberg, Seth M. ; Giaccone, Guiseppe ; Rosenberg, Steven A. ; Avital, Itzhak. / The GYMSSA trial : a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone. In: Trials. 2009 ; Vol. 10. pp. 121.
@article{7dc3fa439177451aaae019fccd4706a4,
title = "The GYMSSA trial: a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone.",
abstract = "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. DESIGN: 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. TRIAL REGISTRATION: ClinicalTrials.gov ID. NCT00941655.",
author = "Kerkar, {Sid P.} and Kemp, {Clinton D.} and Austin Duffy and Kammula, {Udai S.} and Schrump, {David S.} and Kwong, {King F.} and Martha Quezado and Goldspiel, {Barry R.} and Aradhana Venkatesan and Ann Berger and Melissa Walker and Toomey, {Mary Ann} and Steinberg, {Seth M.} and Guiseppe Giaccone and Rosenberg, {Steven A.} and Itzhak Avital",
year = "2009",
doi = "10.1186/1745-6215-10-121",
language = "English (US)",
volume = "10",
pages = "121",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

}

TY - JOUR

T1 - The GYMSSA trial

T2 - a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone.

AU - Kerkar, Sid P.

AU - Kemp, Clinton D.

AU - Duffy, Austin

AU - Kammula, Udai S.

AU - Schrump, David S.

AU - Kwong, King F.

AU - Quezado, Martha

AU - Goldspiel, Barry R.

AU - Venkatesan, Aradhana

AU - Berger, Ann

AU - Walker, Melissa

AU - Toomey, Mary Ann

AU - Steinberg, Seth M.

AU - Giaccone, Guiseppe

AU - Rosenberg, Steven A.

AU - Avital, Itzhak

PY - 2009

Y1 - 2009

N2 - 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. DESIGN: 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. TRIAL REGISTRATION: ClinicalTrials.gov ID. NCT00941655.

AB - 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. DESIGN: 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. TRIAL REGISTRATION: ClinicalTrials.gov ID. NCT00941655.

UR - http://www.scopus.com/inward/record.url?scp=77449140153&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77449140153&partnerID=8YFLogxK

U2 - 10.1186/1745-6215-10-121

DO - 10.1186/1745-6215-10-121

M3 - Article

C2 - 20030854

AN - SCOPUS:77449140153

VL - 10

SP - 121

JO - Trials

JF - Trials

SN - 1745-6215

ER -