A randomized clinical trial of best supportive care compared with best supportive care with chemotherapyin advanced unresectable or metastatic esophageal cancer - PECS

Tata Memorial Hospital0 个研究点目标入组 400 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 <= 2 x upper limit normal (ULN), AST/ALT/ ALP <= 2.5 x ULN, S. albumin >= 30 g/L.
•Renal function- Creatinine <= 1.5 ULN, Creatinine clearance > 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.

•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.

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