Comparing radiotherapy and observation for residual seminoma after chemotherapy
Official title: FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial
Run by Tata Memorial Centre · NCT05142982 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Men only |
| Enrollment | 74 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Mumbai, Maharashtra and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2021 |
| Main results expected | December 15, 2029 |
| Study ends | December 15, 2029 |
| Registry record updated | February 11, 2025 |
| Trial ID | NCT05142982 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years with a histological diagnosis of classical seminoma and measurable residual masses after chemotherapy.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the therapeutic research in seminomas has been slow, this structured approach may provide new insights, although similar studies have not been widely reported.
Who can join: the full rules
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 it's running
-
Dr Vedang Murthy
Navi Mumbai, Maharashtra, India Recruiting -
Tata Memorial Centre
Mumbai, Maharashtra, India Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Primary retroperitoneal lymph node surgery versus chemotherapy for good‑prognosis metastatic testicular cancer
This study will test whether primary RPLND (surgery) instead of standard chemotherapy leads to fewer side effects and better quality of life for men 18 and older with good‑prognosis metastatic testicular cancer.
-
De-escalation treatments for stage II seminoma
This study is testing whether less intense treatments for stage II seminoma can help patients feel better and manage their cancer just as well as standard treatments.
-
Robot-assisted surgery for low-volume metastatic seminoma
This study is testing if robot-assisted surgery can help patients with low-volume metastatic seminoma avoid long-term side effects and improve their quality of life while also figuring out how to personalize their treatment.
-
Robot-assisted biopsy for testicular cancer
This study is testing a new robot-assisted method for taking biopsies in men with testicular cancer to see if it can more accurately find hidden cancer and reduce unnecessary treatments.
-
De-escalation treatment for early-stage seminoma
This study is testing whether giving less treatment after surgery for early-stage seminoma can still be effective while reducing side effects for patients.
-
Using microRNA to improve testicular cancer management
This study is testing if a specific microRNA can help doctors better detect and manage testicular cancer by identifying active tumor cells in patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.