A Phase 3 interventional study of cisplatin and fluorouracil in Gastric Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Terminated at 18 sites in 5 countries. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2012-09-24.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery alone or surgery combined with chemotherapy is more effective in treating stomach cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage II, stage III, or stage IV stomach cancer.
OBJECTIVES:
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to center, primary tumor category (cT3 or cT4), localization of tumor (upper third including cardia II or III vs middle and lower third), gender, and histological subtype (intestinal vs nonintestinal). Patients are randomized to one of two treatment arms.
Patients undergo resection and lymphadenectomy on days 57-63 of the second course of chemotherapy.
Quality of life is assessed before randomization, every 3 months for 1 year and at 2 years after randomization.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, then every 3 months thereafter until death.
PROJECTED ACCRUAL: A total of 360 patients (180 per arm) will be accrued for this study over 4 years.
2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's enrollment of 144 is above the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically proven stage II-IV adenocarcinoma of the stomach including cardia carcinoma types II and III
No evidence of peritoneal carcinomatosis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
This study is terminated, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC