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A PHASE II TRIAL OF NEOADJUVANT CISPLATIN-FLUOROURACIL CHEMOTHERAPY, SURGERY, AND INTRAPERITONEAL (IP) FLOXURIDINE (FUdR) PLUS LEUCOVORIN IN PATIENTS WITH GASTRIC CANCER


Phase 2
N/A
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

A PHASE II TRIAL OF NEOADJUVANT CISPLATIN-FLUOROURACIL CHEMOTHERAPY, SURGERY, AND INTRAPERITONEAL (IP) FLOXURIDINE (FUdR) PLUS LEUCOVORIN IN PATIENTS WITH GASTRIC CANCER


OBJECTIVES: I. Evaluate the efficacy and toxicity of neoadjuvant cisplatin/fluorouracil
(CDDP/5-FU) followed by surgery followed by adjuvant intraperitoneal floxuridine/leucovorin
in patients with high-risk gastric cancer. II. Assess the quality of life and cost-benefit
ratio associated with this treatment. III. Evaluate the sensitivity, specificity, and
overall staging accuracy of laparoscopy with or without laparoscopic ultrasound in
predicting the resectability rate (with and without neoadjuvant CDDP/5-FU), response to
chemotherapy, and accuracy when compared to pathologic findings. IV. Correlate the presence
of mutated vs. wild-type p53 suppressor oncogenes in endoscopic biopsies and resected tumor
specimens with clinical outcome (defined as downstaging, failure pattern, and disease-free
and overall survival) in patients treated with and without neoadjuvant CDDP/5-FU.

OUTLINE: The following acronyms are used: CDDP Cisplatin, NSC-119875 CF Leucovorin calcium,
NSC-3590 5-FU Fluorouracil, NSC-19893 FUDR Floxuridine, NSC-27640 2-Drug Combination
Chemotherapy followed by Surgery followed by Single-Agent Chemotherapy with Drug Modulation.
CDDP/5-FU; followed by total or subtotal radical gastrectomy with D2 dissection; followed by
FUDR; with CF.

PROJECTED ACCRUAL: A total of 50 patients will be entered over 2-2.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Microscopically confirmed adenocarcinoma of the stomach or
gastroesophageal junction Reviewed by Department of Pathology of participating institution
Stage II-IV (T2, N1-2, M0 or T3-4, any N, M0) by physical exam, CT, and laparoscopy
Potentially curable by surgery Suspected sites of metastasis proven M0 prior to entry

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 60%-100%
Hematopoietic: WBC at least 4,000 Platelets at least 150,000 Hepatic: Bilirubin less than
2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than
50 mL/min BUN no greater than 30 mg/dL Cardiovascular: No NYHA class III/IV status No
active angina No myocardial infarction within 6 months No significant ventricular
arrhythmia requiring medication No clinically significant conduction system abnormality
Other: No serious intercurrent infection No nonmalignant medical illness that is
uncontrolled or precludes study participation No psychiatric disorder that precludes
informed consent No clinically significant auditory impairment No second malignancy within
5 years except: Basal cell skin cancer Carcinoma in situ of the cervix No pregnant or
nursing women Negative pregnancy test required of fertile women Effective contraception
required of fertile patients

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David Paul Kelsen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064831

NCT ID:

NCT00002783

Start Date:

May 1996

Completion Date:

Related Keywords:

  • Gastric Cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the stomach
  • Stomach Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021