RESPONSE OF CANCER DRUGS BEFORE SURGERY IN ESOPHAGEAL CANCER AND ALSO COMPARING TWO DIFFERENT CANCER DRUGS COMBINATIONS CISPLATIN PLUS 5FU AND PACLITAXEL AND CARBOPLATI
Phase 2
- Conditions
- Health Condition 1: null- Carcinoma esophagus
- Registration Number
- CTRI/2017/09/009658
- Lead Sponsor
- ALL INDIA INSTITUTE OF MEDICAL SCIENCES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age <70 years
2. Squamous cell carcinoma of esophagus and gastroesophageal junction
3. Good performance status- ECOG (Eastern cooperative oncology group) 0,1 and 2
4. Imaging suggests potentially operable cases (Up to T4a stage)
Exclusion Criteria
1. Medically inoperable cases like poor performance status ECOG >2
2. Gross tumor infiltration in to the mediastenal structure like- tracheal infiltration, large contact with aorta, atrium involvement
3. Cases with distant Metastasis
4. Carcinoma involving cervical esophagus
5. Patient who have already received radiotherapy or chemotherapy
6. Patient refused for consent for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the radiological response rate to neoadjuvant chemotherapy in carcinoma esophagus by PERCIST (positron emission tomography response criteria in solid tumors) <br/ ><br>2. omparison of the response in between two chemotherapy regimens ( Paclitaxel +Carboplatin and Cisplatin+5 FU) <br/ ><br>Timepoint: 3 CYCLE
- Secondary Outcome Measures
Name Time Method 1. Pathological response assessment by Mandard tumor regression grading system,Assessment of chemotherapy induced toxicity as per Common Terminology Criteria for Adverse Events (CTCAE version 4.0),Assessment of Operative morbidities and mortality, Assessment of Progression -free survival (PFS) â??It will be measured from the date of randomization to the date of first evidence of relapse, progression or death due to any cause, whichever will be observed first, Assessment of resectability rateTimepoint: AFTER SURGERY