Health Condition 1: null- Localized Esophageal cancer
Conditions
Interventions
Intervention1: Neoadjuvant Chemotherapy: NACT arm: Paclitaxel (80 mg/sq m) and Carboplatin (AUC 2) administered weekly (on days 1, 8, 15, 22, 29 and 36 of treatment).
Control Intervention1: Neoadjuvan
Sponsors
Tata MemorialHospital
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rates (CR + PR )in the two groupsTimepoint: Not Applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Perioperative morbidity and mortality 2.Quality of life 3.Disease free and overall survival Timepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactC S Pramesh
Outcome results
None listed