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

J

Japan Clinical Oncology Group

Status and phase

Completed
Phase 3

Conditions

Gastric Neoplasm

Treatments

Drug: Gastrectomy+ chemotherapy
Procedure: Gastrectomy with D2 or greater lymph node dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT00147147
C000000067
JCOG9206-2

Details and patient eligibility

About

To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients.

Full description

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.

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems