NCT01608464

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is aimed at improving the outcome of resectable non PET responders, esophageal carcinoma, by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.

Conditions

• Carcinoma of Esophagus

Interventions

Type	Name	Description
DRUG	irinotecan and docetaxel	combination of irinotecan and docetaxel regimen for 2 cycles, recycling every 21 days Irinotecan 100 mg/m2 by intra venous infusion over 2 hours in day1 and docetaxel 40 mg/m2 over one hour will be given on day 1 Assessment by PET scan and CT chest and abdomen will be done 2-3 weeks after end of 2nd cycle of irinotecan and docetaxel
DRUG	Cisplatin, fluorouracil and concurrent radiation therapy	Cisplatin, fluorouracil and concurrent radiation therapy 50 Gy in 25 fractions over 5 weeks with cisplatin 75 mg/m2 on first day of week 1 and week 5 and fluorouracil 750 mg/m2 daily by continuous intra venous infusion at Day 1 and Day 29 of Radiation therapy for 4 days.

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2012-05-31
• Last updated: 2018-08-10

Locations

1 site across 1 country: Saudi Arabia