RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus

• Status: Terminated
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Scientific Research and Information Technology, Poland
• Treatments: Cisplatin; Fluorouracil

Criteria

Inclusion Criteria:

• Informed consent

• Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC classification), primary squamous cell carcinoma of the thoracic esophagus

• Patients' age above 18 years

• General condition with Karnofsky performance status of >70

• Circulatory and pulmonary capacity at normal range (FEV1 >60%; FVC >60%, NYHA I-II, cardiac output >40%)

• Normal function of the bone marrow (RBC >3,5 T/l; PLT >100 G/l)

• Normal renal (creatinine <1.5 of the upper limit) and liver (AST or ALT <2,5 of the upper limit or bilirubin <1,5 of the upper limit) function

Exclusion Criteria:

• Metastatic disease

• Synchronous malignancy

• History of other cancer within 5 years prior to esophageal cancer treatment

• History of allergic reaction to cisplatin of 5-fluorouracil

• Systemic infection

• Pregnancy or female patients in childbearing age without proper contraceptives.