Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Terminated

CT.gov ID

NCT00004099

Collaborator

(none)

144

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Procedure: neoadjuvant therapy	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

144 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Phase III Study of Preoperative Chemotherapy Followed by Surgery Versus Surgery Alone in Locally Advanced Gastric Cancer (cT3 and cT4NxM0)

Study Start Date :

Jul 1, 1999

Actual Primary Completion Date :

Feb 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut Jules Bordet	Brussels	Belgium	1000
2	National Cancer Institute of Egypt	Cairo	Egypt
3	Robert Roessle Klinik	Berlin	Germany	D-13122
4	Medizinische Klinik I	Dresden	Germany	D-01307
5	Universitaetsklinik Duesseldorf	Duesseldorf	Germany	D-40225
6	Department of Medicine III	Erlangen	Germany	D-91054
7	Kliniken Essen - Mitte	Essen	Germany	D-45136
8	Evangelisches Bethesda Krankenhaus GmbH	Essen	Germany	D-45355
9	Krankenhaus Nordwest	Frankfurt	Germany	D-60488
10	Klinikum der J.W. Goethe Universitaet	Frankfurt	Germany	D-60590
11	Universitatsklinik - Saarland	Homburg	Germany	D-66421
12	Klinik & Poliklinik fur Strahlentherapie der Universitat zu Koln	Koln	Germany	D-50924
13	Kreiskrankenhaus Meissen	Meissen	Germany	D-01657
14	Westfaelische Wilhelms-Universitaet	Muenster	Germany	DOH-48149
15	Klinikum Rechts Der Isar/Technische Universitaet Muenchen	Munich	Germany	D-81675
16	Staedtisches Krankenhaus	Solingen	Germany	D-42653
17	Academisch Ziekenhuis Maastricht	Maastricht	Netherlands	6202 AZ
18	Instituto Portugues de Oncologia Centro do Porto, SA	Porto	Portugal	4200