Actively Recruiting
Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma
Led by Tata Memorial Centre · Updated on 2025-02-11
74
Participants Needed
2
Research Sites
419 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of classical seminoma
- Primary tumor site in testis, mediastinum, or retroperitoneum
- Stage IIB to IIIC seminoma according to AJCC 8th edition
- Age over 18 years
- Karnofsky Performance Status of at least 70
- FDG PET-CT scan done at least 12 weeks after first-line chemotherapy showing persistent measurable residual mass
- Patient willing and reliable for follow-up and quality of life assessments
You will not qualify if you...
- Histology other than classical seminoma
- Incomplete first-line chemotherapy
- Prior radiotherapy to the involved region
- Inability to safely deliver adequate radiotherapy dose as assessed by a radiation oncologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Tata Memorial Centre
Mumbai, Maharashtra, India, 410210
Not Yet Recruiting
2
Dr Vedang Murthy
Navi Mumbai, Maharashtra, India, 410210
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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