Actively Recruiting
FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial
Led by Tata Memorial Centre · Updated on 2025-02-11
74
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Testicular tumors make up 1% of all cancers in males, with germ cell tumors representing 95% of these. Approximately half of these are seminomas. Despite standard chemotherapy treatments, 60-80% of patients still have residual disease. Researchers are studying the role of PET-CT imaging to better identify patients with stage IIB-IIIC seminomatous germ cell tumors who still have visible tumors after chemotherapy and may benefit from targeted radiotherapy. In this trial, patients are randomly assigned to either receive radiotherapy or observation. Those in the radiotherapy group will receive 30-36 Gy in daily doses of 1.8-2.0 Gy using a 3-dimensional conformal technique, five days a week. Patients are grouped based on the size of their residual tumor. The observation group will be monitored with FDG PET-CT scans every three to six months to track residual tumor status. Participants will be followed for two years to assess progression-free survival, locoregional control, overall survival, need for second-line therapies, and radiation-related side effects. Quality of life will also be measured using patient-reported questionnaires. The study aims to better understand treatment outcomes and side effects to guide future research in seminoma care.
CONDITIONS
Brief 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 (AJCC 8th edition)
- Age over 18 years
- Karnofsky Performance Status of at least 70
- Persistent measurable residual mass on FDG PET-CT at least 12 weeks after first-line chemotherapy
- Willingness and reliability 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
- Unable to safely receive adequate radiotherapy dose as assessed by a radiation oncologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Radiotherapy delivered over several weeks; observation duration varies with monitoring schedule.
Participants randomized to the radiotherapy arm receive 30-36 Gy in conventional fractionation of 1.8-2.0 Gy per fraction using 3-dimensional conformal technique, delivered five days a week. Participants randomized to the observation arm are monitored without active intervention.
Radiotherapy visits five days a week during treatment; observation includes FDG PET-CT scans every 3 to 6 months
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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