A Randomized Controlled Trial of Chemotherapy With 5FU and Cisplatin Before and After Surgery for Stage II,III Squamous Cell Carcinoma of the Thoracic Esophagus:JCOG9907

Japan Clinical Oncology Group24 sites in 1 country330 target enrollmentMay 2000

ConditionsEsophageal Neoplasms Carcinoma, Squamous Cell

DrugsSurgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2 (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Esophageal Neoplasms
Sponsor: Japan Clinical Oncology Group
Enrollment: 330
Locations: 24
Primary Endpoint: Disease free survival
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma

Detailed Description

The previous study JCOG9204 showed that postoperative adjuvant chemotherapy with cisplatin and fluorouracil has a detectable preventive effect on relapse in patients with esophageal squamous cell carcinoma compared with surgery alone.(J Clin Oncol 2003;21:4592-4596) Therefore the standard treatment for stage II and III esophageal cancer is adjuvant chemotherapy after surgery.

Registry

clinicaltrials.gov

Start Date

May 2000

End Date

May 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Japan Clinical Oncology Group

Eligibility Criteria

Inclusion Criteria

•histologically proven squamous cell carcinoma of the thoracic esophagus
•pathologic stages IIa, IIb, III except T4
•an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
•no previous history of chemotherapy nor radiotherapy
•an essentially normal clinical laboratory profile (white blood cell count or WBC, \>=4,000 /mm3; hemoglobin or Hb, \>=10g/dl; platelet count or Plt, \>=100,000 /mm3; total serum bilirubin\<=1.2 mg/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT no higher than twice normal; creatinine or CRTN, \<=1.2 mg/dl; creatinine clearance or CCr, \>=60 ml/minute; and arterial oxygen tension or PaO2, \>=65 torr
•oral or written informed consent obtained before randomization