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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
170
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
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.
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group
Time frame: 5 yrs
Rate of conversion from PET non responder to responder with each type of salvage therapy
* Failure Free Survival for each treatment group * Overall Survival for each treatment group * ERCC1 as a predictor of failure of response to cisplatin based chemotherapy in neo adjuvant setting.
Time frame: 5 yrs
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