Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma
FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial
Tata Memorial Centre
74 participants
Dec 1, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- Histological diagnosis of classical seminoma
- Primary site - testis, mediastinum or retroperitoneum
- Stage IIB-IIIC (AJCC 8th edition)
- Age>18 years
- Karnofsky Performance Status at least 70
- A response assessment FDG PETCT scan done at least twelve weeks after the first line chemotherapy, showing a persistent measurable residual mass
- Patient willing and reliable for follow up and QOL.
Exclusion Criteria4
- Histology other than classical seminoma
- Non completion of planned first-line chemotherapy
- Prior history of radiotherapy to the involved region
- Inability to deliver adequate radiotherapy dose safely based on assessment by radiation oncologist
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Interventions
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.
Locations(2)
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NCT05142982