Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma
NCT ID: NCT05142982
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
74 participants
INTERVENTIONAL
2021-12-01
2029-12-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiotherapy
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.
Radiotherapy
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.
Observation
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.
No interventions assigned to this group
Interventions
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Radiotherapy
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
MALE
No
Sponsors
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Tata Memorial Centre
OTHER
Responsible Party
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Dr Vedang Murthy
Professor
Locations
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Tata Memorial Centre
Mumbai, Maharashtra, India
Dr Vedang Murthy
Navi Mumbai, Maharashtra, India
Countries
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Facility Contacts
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Other Identifiers
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PROsem
Identifier Type: -
Identifier Source: org_study_id
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