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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147147

Enrollment

280

Registered

2005-09-07

Start date

1993-01-31

Completion date

2004-03-31

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Neoplasm

Keywords

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

Brief summary

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

Detailed 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.

Interventions

PROCEDUREGastrectomy with D2 or greater lymph node dissection

DRUGGastrectomy+ chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Relapse-free survival	—
the site of recurrence	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026