Pre-op Chemo-RT w/CDDP/5FU vs Chemo w/ Docetaxel/Irinotecan in PET Non Responder Resectable Esophagus Cancer

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to improve their outcome by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.

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

Details

• Lead Sponsor: King Faisal Specialist Hospital & Research Center
• Treatments: Camptothecin; Cisplatin; Docetaxel; Fluorouracil; Irinotecan

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.