Tata Memorial Centre
Dr Vedang Murthy
Testicular tumors account for 1% of all cancers in males and germ cell tumors comprise 95% of all testicular cancers. Seminomas consist of around 50% of cases. However,adequate information is not there as 60- 80% residual disease is seen even after with the standard management of chemotherapy. With the advent of functional imaging there was hope that it could aid in more accurately targeting these tumors to systematically evaluate the role of PET-CT imaging in identifying patients diagnosed with stage IIB-IIIC seminomatous germ cell tumor, with residual visible tumor post chemotherapy who would benefit with loco regional radiotherapy. The therapeutic research in Seminomashas been relatively slow and such structured studies can allow analysis of large number of patients to report on acute and late effect of treatment outcomes using CTCAE and QOL (EORTC QLQ C-30) in these cancers. We hope that we will get help in identifying thrust areas for future research through this study.
Seminoma
Radiotherapy
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 74 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial |
Actual Study Start Date : | December 15, 2021 |
Estimated Primary Completion Date : | December 15, 2029 |
Estimated Study Completion Date : | December 15, 2029 |
Arm | Intervention/treatment |
---|---|
Experimental: Radiotherapy Patients randomized to the test arm will undergo radiotherapy to the residual mass. Patients will be stratified by the size of the residual mass in shortest dimension being <3 cm or > 3 cm.A dose of 30-36 Gy in conventional fractionation of 1.8-2.0 Gy per fraction using 3-dimensional conformal technique. Radiotherapy will be delivered five days a week. |
|
No Intervention: Observation Patients randomized to the standard arm will be observed and the status of residual mass monitored with an FDG PETCT scan done at three to six monthly intervals. |
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Tata Memorial Centre
Mumbai, Maharashtra, India, 410210
Not yet recruiting
Dr Vedang Murthy
Navi-Mumbai, Maharashtra, India, 410210