Status:
TERMINATED
A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Esophageal Neoplasms
Carcinoma, Squamous Cell
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
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 carc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- severe heart diseases
- uncontrollable hyper tension or diabetes mellitus
- severe pulmonary dysfunction
- HBs positive
- active bacterial infection
- synchronous or metachronous (within 5 years) malignancy
- pregnant female
- psychiatric medication
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
End Date :
May 1 2009
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00190554
Start Date
May 1 2000
End Date
May 1 2009
Last Update
September 22 2016
Active Locations (24)
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1
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
2
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan, 260-8670
3
Tokyo Dental College Ichikawa General Hospital
Ichikawashi,Sugano,5-11-13, Chiba, Japan, 2728513
4
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577