Clinical trial NCT00147147: Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by UFT in Serosa-positive Gastric Cancer (JCOG9206-2)
Official title: Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by Oral Fluorouracil (UFT) in Serosa-positive Gastric Cancer (JCOG9206-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Neoplasm
Keywords: gastric neoplasm
gastrectomy
adjuvant chemotherapy
randomized trial
T3 and T4 carcinoma of the stomach/Gastric Neoplasm
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-07
Enrollment: 280
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Relapse-free survival
measure: the site of recurrence
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Gastric Surgery Division, National Cancer Center Hospital
state: Tokyo
Study officials:
affiliation: Sakai Municipal Hospital
name: Hiroshi Furukawa, MD, PhD
role: STUDY_CHAIR
References:
citation: Miyashiro I, Furukawa H, Sasako M, Yamamoto S, Nashimoto A, Nakajima T, Kinoshita T, Kobayashi O, Arai K; Gastric Cancer Surgical Study Group in the Japan Clinical Oncology Group. Randomized clinical trial of adjuvant chemotherapy with intraperitoneal and intravenous cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer versus curative resection alone: final results of the Japan Clinical Oncology Group trial JCOG9206-2. Gastric Cancer. 2011 Aug;14(3):212-8. doi: 10.1007/s10120-011-0027-3. Epub 2011 Feb 19.