Randomized Phase III Study of Preoperative Chemotherapy Followed by Surgery Versus Surgery Alone in Locally Advanced Gastric Cancer (cT3 and cT4NxM0)
18 Years
69 Years
Both
Gastric Cancer
Trial Information
Randomized Phase III Study of Preoperative Chemotherapy Followed by Surgery Versus Surgery Alone in Locally Advanced Gastric Cancer (cT3 and cT4NxM0)
OBJECTIVES:
- Compare overall survival in patients with locally advanced gastric cancer treated with
surgery alone or in combination with neoadjuvant cisplatin, leucovorin calcium and
fluorouracil.
- Compare these two regimens in terms of the rate of complete resection, time to
progression, and morbidity in these patients.
- Evaluate toxicity of and disease response to neoadjuvant chemotherapy in these
patients.
- Evaluate quality of life and performance status in these patients pre- and post-surgery
and compare quality of life for both regimens.
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.
- Arm I: Patients receive cisplatin IV over 1 hour on days 1, 15, and 29. Patients also
receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on
days 1, 8, 15, 22, 29, and 36. A second course is administered beginning 2 weeks later
in the absence of disease progression or unacceptable toxicity.
Patients undergo resection and lymphadenectomy on days 57-63 of the second course of
chemotherapy.
- Arm II: Patients undergo resection and lymphadenectomy within 14 days of randomization.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven stage II-IV adenocarcinoma of the stomach including cardia
carcinoma types II and III
- Locally resectable disease
- No distant metastases except M1 lymph nodes
- No evidence of peritoneal carcinomatosis
- Free tumor cells in lavage at laparoscopy allowed
- No uncontrolled bleeding of the primary tumor
- No gastric outlet syndrome or complete tumor stenosis that would require total
parenteral nutrition
PATIENT CHARACTERISTICS:
Age:
- 18 to 69
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 4,000/mm^3
- Absolute neutrophil count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- Prothrombin rate at least 70%
Renal:
- Creatinine no greater than 1.25 times ULN
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No prior atrial or ventricular arrhythmias
- No prior congestive heart failure
- No myocardial infarction within the past 6 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior or concurrent neoplasm except curatively treated nonmelanoma skin
cancer or carcinoma in situ of the cervix
- No active infection
- No allergy to protocol drugs
- No dementia or significantly altered mental status
- No other serious medical condition that would prevent compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No filgrastim (G-CSF) within 48 hours prior to chemotherapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
- No prior stent implantation
- No prior laser therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Christoph Schuhmacher
Investigator Role:
Study Chair
Investigator Affiliation:
Technische Universität München
Authority:
United States: Federal Government
Study ID:
EORTC-40954
NCT ID:
NCT00004099
Start Date:
July 1999
Completion Date:
Related Keywords:
- Gastric Cancer
- stage II gastric cancer
- stage III gastric cancer
- stage IV gastric cancer
- intestinal adenocarcinoma of the stomach
- diffuse adenocarcinoma of the stomach
- mixed adenocarcinoma of the stomach
- Stomach Neoplasms
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