Palliative chemotherapy in esophageal cancer for survival

Phase 3

• Conditions: Health Condition 1: null- Advanced unresectable or metastatic esophageal cancer

• Registration Number: CTRI/2016/01/006474
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 400

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 <= 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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified