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

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213486
• Other study ID #: 2001/141/HP
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: October 27, 2005
• Start date: June 2002
• Est. completion date: December 2004

Study information

• Verified date: September 2005
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Drug:
• irinotecan

Locations

Country	Name	City	State
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan
Secondary	toxicity profile
Secondary	overall survival rate at one and two years