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


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Neoplasms

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan

Principal Investigator

Pierre MICHEL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

FFCD

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2001/141/HP

NCT ID:

NCT00213486

Start Date:

June 2002

Completion Date:

December 2004

Related Keywords:

  • Esophageal Neoplasms
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms

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