A Trial Comparing Pre-operative Chemo-radiotherapy With Cisplatin and Fluorouracil Versus Chemotherapy With Docetaxel and Irinotecan in PET Non Responders Resectable Cancer Esophagus: a Multicenter Study
Conditions
Carcinoma of Esophagus
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Randomized trial,, Pre-operative chemo-RT with CDDP and 5-FU, Multicenter study
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Intervention
Name: irinotecan and docetaxel Type: Drug
Name: Cisplatin, fluorouracil and concurrent radiation therapy Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to improve their outcome by either changing the chemotherapy drugs or giving then radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 14 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically proven squamous cell or adenocarcinoma of the thoracic esophagus and gastro-esophageal junction.

- No distant metastases.

- Signed written informed consent.

- Age less than 75 years.

- Potentially resectable tumor (radiological evidence of resection with no residual disease).

- ECOG 0 to 2.

- Normal serum creatinine and adequate hepatic function, serum bilirubin less than 30 mmol/l, serum alkaline phosphatase less than 2 times upper limit of normal and ALT and AST of less than 4 upper limits of normal.

- Normal bone marrow function with absolute neutrophile count of more than 1500/ml, hemoglobin more than 80 gm/L and platelets more than 100,000 /ml

Exclusion Criteria:

1. Serious underlying medical condition which could impair the patient ability to participate in the clinical trial or comply to follow up

2. Prior treatment with other anti cancer therapy or radiation therapy.

3. Legal incapacity.

4. Previous malignancy within 5 years except adequately treated non melanomatous skin cancer or in situ cervical cancer.

5. Psychiatric or mental disorder precluding the understanding of the information of the trial topics and giving valid informed consent.
Location
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
Status: Recruiting
Contact: Shouki Bazarbashi, MD - 966-1-4423799 - bazarbashi@gmail.com
Start Date
May 2012
Completion Date
May 2017
Sponsors
King Faisal Specialist Hospital & Research Center
Source
King Faisal Specialist Hospital & Research Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page