RecruitingNot ApplicableNCT05142982

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


Sponsor

Tata Memorial Centre

Enrollment

74 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

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: MALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • Histological diagnosis of classical seminoma
  • Primary site - testis, mediastinum or retroperitoneum
  • Stage IIB-IIIC (AJCC 8th edition)
  • Age>18 years
  • Karnofsky Performance Status at least 70
  • A response assessment FDG PETCT scan done at least twelve weeks after the first line chemotherapy, showing a persistent measurable residual mass
  • Patient willing and reliable for follow up and QOL.

Exclusion Criteria4

  • Histology other than classical seminoma
  • Non completion of planned first-line chemotherapy
  • Prior history of radiotherapy to the involved region
  • Inability to deliver adequate radiotherapy dose safely based on assessment by radiation oncologist

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONRadiotherapy

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.


Locations(2)

Tata Memorial Centre

Mumbai, Maharashtra, India

Dr Vedang Murthy

Navi Mumbai, Maharashtra, India

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05142982


Related Trials