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

University Hospital, Rouen

Status and phase

Completed

Phase 2

Conditions

Esophageal Neoplasms

Treatments

Drug: irinotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT00213486

2001/141/HP

Details and patient eligibility

About

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.

Full description

Chemotherapy with weekly cisplatin 30 mg/m2 AND Irinotecan 60 mg/m2 was administered at days1,8,22,29 and concurrently with radiotherapy t days 43,50,64,71. Radiotherapy was delivered day 43 to 75 with 50Gy in 25 fractions/5 weeks.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed
performance status <OR=2 (ECOG)
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