Comparative study of chemotherapy in esophagus carcinoma.
Phase 4
- Conditions
- Health Condition 1: null- All patients of Ca Esophagus or GE Junction planned for NACT in thoracic joint clinic will be included if they are fit to receive platinum based chemotherapy
- Registration Number
- CTRI/2014/04/004516
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 350
Inclusion Criteria
Inclusion Criteria:
1.Histologic confirmation of pathology: Squamous cell or adenocarcinoma of ca esophagus or GE junction.
2.Age 18 years or older
3.Eastern Cooperative Oncology Group performance status of 0 to 2
4.Adequate bone marrow, hepatic, renal, and pulmonary function
5.Willingness to provide written informed consent.
Exclusion Criteria
Exclusion criteria shall be:
1.Prior therapy for carcinoma esophagus or GE junction
2.Evidence of distant metastases
3.Received any of the investigational product in the last 30 days
4.Patients who were pregnant or lactating
5.Patients with uncontrolled or severe cardiovascular disease
6.Pre-existing neurotoxicity greater than National Cancer Instituteâ??Common Toxicity Criteria (NCI-CTC) grade 2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary- <br/ ><br>Efficacy of these two regimens (TRG Post Chemotherapy) <br/ ><br>Timepoint: 3 years
- Secondary Outcome Measures
Name Time Method Secondary - <br/ ><br>Safety of these two regimens <br/ ><br>QOL in these two regimens <br/ ><br>Hospital admission required after chemotherapy administration <br/ ><br>R0 resection rate <br/ ><br>Progression free survival <br/ ><br>Overall Survival <br/ ><br>Timepoint: 3 years