Clinical trial · Interventional
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
NCT00190554CI-TRIAL-00023974terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2+Surgery | Drug | — | UNRESOLVED |
| Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- year
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- year
- measure
- Toxicity of chemotherapy
- timeFrame
- year
- measure
- Operative morbidity
- timeFrame
- year
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHirao 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. Epub 2011 Sep 14. PMID 21918956