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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190554

Enrollment

330

Registered

2005-09-19

Start date

2000-05-31

Completion date

2009-05-31

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Squamous Cell, Esophageal Neoplasms

Keywords

esophageal cancer, squamous cell carcinoma, esophagectomy, neoadjuvant chemotherapy, esophageal squamous cell carcinoma

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 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.

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Disease free survival	year

Secondary

Measure	Time frame
Overall survival	year
Toxicity of chemotherapy	year
Operative morbidity	year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026