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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 3
N/A
75 Years
Not Enrolling
Both
Esophageal Neoplasms, Carcinoma, Squamous Cell

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Principal Investigator

Nobutoshi Ando, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Tokyo Dental College Ichikawa General Hospital

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG9907

NCT ID:

NCT00190554

Start Date:

May 2000

Completion Date:

May 2009

Related Keywords:

  • Esophageal Neoplasms
  • Carcinoma, Squamous Cell
  • esophageal cancer
  • squamous cell carcinoma
  • esophagectomy
  • neoadjuvant chemotherapy
  • esophageal squamous cell carcinoma
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

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