Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Seminoma | Seminoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- 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.
- interventionNames
- Radiation: Radiotherapy
- type
- NO_INTERVENTION
- label
- Observation
- description
- 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.
Primary outcomes (1)
- measure
- Progression free survival(PFS)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
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