Comparing radiotherapy and observation for residual seminoma after chemotherapy
FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial
This study is testing whether giving radiotherapy or just watching closely is better for patients with advanced seminoma who still have leftover masses after chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Mumbai, Maharashtra and 1 other locations) |
| Trial ID | NCT05142982 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of radiotherapy versus observation in patients with advanced seminoma who have residual masses after chemotherapy. It utilizes FDG-PET CT imaging to identify patients with stage IIB-IIIC seminomatous germ cell tumors, aiming to determine which patients may benefit from additional radiotherapy. The study will analyze treatment outcomes, including acute and late effects, using standardized assessment tools. By gathering data from a large patient cohort, the research seeks to identify key areas for future investigation in seminoma treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with a histological diagnosis of classical seminoma and measurable residual masses after chemotherapy.
Not a fit: Patients with non-classical seminoma histology or those who have not completed their first-line chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with advanced seminoma, potentially leading to better outcomes and quality of life.
How similar studies have performed: While the therapeutic research in seminomas has been slow, this structured approach may provide new insights, although similar studies have not been widely reported.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histological diagnosis of classical seminoma 2. Primary site - testis, mediastinum or retroperitoneum 3. Stage IIB-IIIC (AJCC 8th edition) 4. Age\>18 years 5. Karnofsky Performance Status at least 70 6. A response assessment FDG PETCT scan done at least twelve weeks after the first line chemotherapy, showing a persistent measurable residual mass 7. Patient willing and reliable for follow up and QOL. Exclusion Criteria: 1. Histology other than classical seminoma 2. Non completion of planned first-line chemotherapy 3. Prior history of radiotherapy to the involved region 4. Inability to deliver adequate radiotherapy dose safely based on assessment by radiation oncologist
Where this trial is running
Mumbai, Maharashtra and 1 other locations
- Tata Memorial Centre — Mumbai, Maharashtra, India (Not_yet_recruiting)
- Dr Vedang Murthy — Navi Mumbai, Maharashtra, India (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.