Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

NCT05142982 · tracked via the Priya Life Science India tracker

Sponsor

Tata Memorial Centre

Phase

Not applicable

Started

2021-12-01

Last updated

2025-02-11

Condition(s) studied

Seminoma

Investigational drug(s) / intervention(s)

Radiotherapy

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.

Study summary

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.

Eligibility

Sex

MALE

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Progression free survival(PFS) — 2 years
• Progression free survival (PFS) is defined as the time period from the date of enrolment in the study till the first observation of disease progression at any site, or death.

Trial sites (2)

Facility	City	Region	Status
Tata Memorial Centre	Mumbai	Maharashtra	Not Yet Recruiting
Dr Vedang Murthy	Navi Mumbai	Maharashtra	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05142982 on ClinicalTrials.gov ↗ ← All trials in India