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Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by Oral Fluorouracil (UFT) in Serosa-Positive Gastric Cancer (JCOG9206-2)


Phase 3
N/A
75 Years
Not Enrolling
Both
Gastric Neoplasm

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Trial Information

Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by Oral Fluorouracil (UFT) in Serosa-Positive Gastric Cancer (JCOG9206-2)


Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection
in serosa-positive gastric cancer patients, a multicenter phase III clinical trial was
conducted by 13 participating centers in Japan. Methods: From January 1993 to March 1998,
268 patients were randomized to either adjuvant chemotherapy (135 pts) or surgery alone (133
pts). The chemotherapy comprised intraperitoneal cisplatin 70 mg/m2 before closing the
abdomen, and after surgery intravenous cisplatin 70 mg/m2 (day 14) and 5-fluorouracil (5-FU)
700 mg/m2 daily (day 14-16), and oral FU (UFT) 267 mg/m2 daily from 4 weeks after surgery
for the next 12 months. The primary endpoint was overall survival. Relapse-free survival and
the site of recurrence were secondary endpoints.

Comparison: gastrectomy with D2 or greater lymph node dissection versus gastrectomy with
adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients.


Inclusion Criteria:



1. Curative operation with D2 or greater lymph node dissection

2. Histologically proven gastric adenocarcinoma

3. Macroscopically serosa-positive (T3-4)

4. No metastases to level 3 - 4 lymph nodes station (N0-2)

5. 75 years or younger

6. Negative peritoneal lavage cytology

7. Adequate organ function WBC >=4000/mm3,Hb >=11.0g/dl,Plt >=100.000/mm3,AST/ALT,
T.Bil, BUN, Creatinine <=2.5 x Normal Upper Limit,Creatinine clearance <=70 ml/min

8. Written informed consent

Exclusion Criteria:

1. Prior chemotherapy or radiotherapy

2. Synchronous or metachronous malignancy in other organs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Principal Investigator

Hiroshi Furukawa, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sakai Municipal Hospital

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG9206-2

NCT ID:

NCT00147147

Start Date:

January 1993

Completion Date:

March 2004

Related Keywords:

  • Gastric Neoplasm
  • gastric neoplasm
  • gastrectomy
  • adjuvant chemotherapy
  • randomized trial
  • T3 and T4 carcinoma of the stomach/Gastric Neoplasm
  • Neoplasms
  • Stomach Neoplasms

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