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

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00190554
First received: September 13, 2005
Last updated: September 20, 2016
Last verified: September 2016

September 13, 2005
September 20, 2016
May 2000
May 2004   (final data collection date for primary outcome measure)
Disease free survival [ Time Frame: year ] [ Designated as safety issue: No ]
Disease free survival
Complete list of historical versions of study NCT00190554 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: year ] [ Designated as safety issue: No ]
  • Toxicity of chemotherapy [ Time Frame: year ] [ Designated as safety issue: Yes ]
  • Operative morbidity [ Time Frame: year ] [ Designated as safety issue: Yes ]
  • Overall survival
  • Toxicity of chemotherapy
  • Operative morbidity
Not Provided
Not Provided
 
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
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Neoplasms
  • Carcinoma, Squamous Cell
  • Drug: Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2
  • Drug: (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2+Surgery
Not Provided
Hirao M, Ando N, Tsujinaka T, Udagawa H, Yano M, Yamana H, Nagai K, Mizusawa J, Nakamura K; Japan Esophageal Oncology Group/Japan Clinical Oncology Group.. Influence of preoperative chemotherapy for advanced thoracic oesophageal squamous cell carcinoma on perioperative complications. Br J Surg. 2011 Dec;98(12):1735-41. doi: 10.1002/bjs.7683.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
330
May 2009
May 2004   (final data collection date for primary outcome measure)

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
Both
up to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00190554
JCOG9907, C000000223
Yes
Not Provided
Not Provided
Not Provided
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Nobutoshi Ando, M.D. Tokyo Dental College Ichikawa General Hospital
Japan Clinical Oncology Group
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP