Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Rouen
• Treatments: Camptothecin; Cisplatin; Irinotecan

Criteria

Inclusion Criteria:

• esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed

• performance status- caloric intake>1500 KCal/d

• serum albumin >32 gr/l

• serum creatinine<120 microgr/l

• total serum bilirubin < 1.5 mg/ml

• no prior chemotherapy or radiotherapy or surgery for esophageal neoplasm

• no prior history of malignancy other than cell carcinoma of the skin, in siyu cervical carcinoma, or head and neck carcinoma with complete response since 3 years

• written informed consent

Exclusion Criteria:

• Gilbert's syndrome

• cardiac disease as NYHA class 3 or 4

• myocardial infarction within the previous 6 months

• metastatic disease

• histologically proved invasion of tracheobronchial tree

• metastatic disease