Overview

A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma

Status:
Terminated

Trial end date:
2009-05-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Japan Clinical Oncology Group

Collaborator:

Ministry of Health, Labour and Welfare, Japan

Treatments:

Cisplatin
Fluorouracil

Criteria

Inclusion Criteria:

1. histologically proven squamous cell carcinoma of the thoracic esophagus

2. pathologic stages IIa, IIb, III except T4

3. an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

4. no previous history of chemotherapy nor radiotherapy

5. 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

6. oral or written informed consent obtained before randomization

Exclusion Criteria:

1. severe heart diseases

2. uncontrollable hyper tension or diabetes mellitus

3. severe pulmonary dysfunction

4. HBs positive

5. active bacterial infection

6. synchronous or metachronous (within 5 years) malignancy

7. pregnant female

8. psychiatric medication