Health Condition 1: null- Advanced unresectable or metastatic esophageal cancer
Conditions
Interventions
Intervention1: Chemotherapy: Inj paclitaxel
Paclitaxel will be administered at a dose of 80 mg/m2in a glass bottle with non-PVC tubing every week untill disease progression.
Control Intervention1: B
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with advanced unresectable or metastatic esophageal and gastroesophageal junction cancer that is not amenable to curative intent therapy. 2. Patients with symptomatic dysphagia or pain as the main symptom due to advanced esophageal cancer will be evaluated in the thoracic disease management group joint clinic for palliative radiotherapy prior to consideration for this trial. 3. Age 18 to 70 years. 4. ECOG performance status 0, 1, 2. [13] 5. If the patient has been treated with curative intent therapy, this therapy should have been completed at least 6 months prior to enrolment. 6. Patient who can give informed consent for the study. 7. Patient does not have any contraindications to receive chemotherapy 8. Adequate organ function • Hematological- Hb > 90 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L. • Liver functions- bilirubin = 30 g/L. • Renal function- Creatinine 50 mL/min. 9. Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
Exclusion criteria
Exclusion criteria: 1.Serious co-morbidities such as, but not limited to severe cardiac failure or severe pulmonary compromise or severe and active infections. 2.Peripheral neuropathy > grade 2. 3.History of hypersensitivity to paclitaxel. 4.Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy other than esophageal cancerfor which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable. 5.Patients on other investigational drugs within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: At Death | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival 2. Quality of lifeTimepoint: 1. At Progression of disease 2. Every 2 months | — |
Countries
India
Contacts
Public ContactBhavesh Bandekar
Tata Memorial Hospital
Outcome results
None listed