Trial | NCT00190554  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    fluorouracil cisplatin ...

  • Study Participants

    330
To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma
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.
Study Started
May 31
2000
Primary Completion
May 31
2004
Study Completion
May 31
2009
Last Update
Sep 22
2016
Estimate

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

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

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

Exclusion Criteria:

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
No Results Posted