Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: Palliative Radiotherapy: Palliative radiotherapy will be given in patients of gallbladder cancer after informed consent, who are not fit for surgery
or chemotherapy.
Intervention2: Pal
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: (i) Pathologically proven gallbladder and bile duct malignancy (ii)Willing to participate in the study. (iii) Not fit for definitive surgery or chemotherapy.
Exclusion criteria
Exclusion criteria: (i) Postop patients. (ii) Previous exposure to radiotherapy or chemotherapy I (iii) Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome- To look for a change in obstructive mass size at 4 weeks after CRT and acute and late toxicities, if any.Timepoint: 1.Size of mass on CECT as per RECIST criteria 1.1 Before and after 4 weeks of radiation therapy. 2.Acute toxicities will be assessed during the radiation therapy and uptil 6 months of CRT while chronic toxicities shall be assessed after 6 months of completion of radiation therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To look for PTBD/stent patency status post CRT, Quality of life (QOL) and 1-year overall survival (OS).Timepoint: 1. PTBD/Stent status shall be assessed after 4 weeks of completion of radiation therapy. 2.QOL shall be assessed before and at 4weeks of completion of radiotherapy and then on subsequent follow ups for 1 year. 3.Survival at 1 year shall be recorded. | — |
Countries
India
Contacts
Public ContactDivyesh Kumar
Post Graduate Medical Education and Research
Outcome results
None listed