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NCT05142982 | Not yet recruiting | Seminoma


Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma
Sponsor:

Tata Memorial Centre

Information provided by (Responsible Party):

Dr Vedang Murthy

Brief 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.

Condition or disease

Seminoma

Intervention/treatment

Radiotherapy

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 74 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : December 15, 2029
Estimated Study Completion Date : December 15, 2029
Arm Intervention/treatment

Experimental: 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.

No Intervention: 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.

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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 Criteria
  • 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

Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

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Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

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Locations


Not yet recruiting

India, Maharashtra

Tata Memorial Centre

Mumbai, Maharashtra, India, 410210

Not yet recruiting

India, Maharashtra

Dr Vedang Murthy

Navi-Mumbai, Maharashtra, India, 410210

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