A study comparing preoperative chemotherapy with preoperative chemoradiotherapy for advanced esophageal (foodpipe) cancer
- Conditions
- Health Condition 1: null- Localized Esophageal cancer
- Registration Number
- CTRI/2013/03/003497
- Lead Sponsor
- Tata MemorialHospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
1.Patients with biopsy or cytology proven squamous esophageal cancer
2.Patients with staging investigations indicating locoregionally advanced disease ? T3,4 with N0/1 tumors (by CT and/or EUS, wherever possible)
3.Surgical plan for total transthoracic esophagectomy
4.American Society of Anesthesiologists (ASA) grade I, II
5.Nutrition SGA A or B
6.Normal hematological and biochemical parameters
1.Patients with localized, early esophageal cancer (T1,2, N0/1 tumors)
2.Patients with tumors grossly infiltrating the aorta or tracheo bronchial tree
3.Patients with distant metastases (supraclavicular and celiac node metastases will not be considered as distant metastases)
4.Patients with low performance status (ECOG score > 1)
5.Patients with extensive pulmonary tuberculosis
6.Patients previously treated with esophageal stenting
7.Patients with pre existing renal disease precluding administration of chemotherapy
8.Patients who have received previous chemotherapy or radiotherapy for the disease
9.Patients with previous history of malignancy
10.Patients unfit for surgical resection
11.Patients below 18 years and above 70 years of age.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rates (CR + PR )in the two groupsTimepoint: Not Applicable
- Secondary Outcome Measures
Name Time Method 1.Perioperative morbidity and mortality <br/ ><br>2.Quality of life <br/ ><br>3.Disease free and overall survival <br/ ><br> <br/ ><br>Timepoint: Not Applicable