NCT05142982

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
44mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Dec 2021Dec 2029

First Submitted

Initial submission to the registry

November 15, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2029

Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

8 years

First QC Date

November 15, 2021

Last Update Submit

February 7, 2025

Conditions

Seminoma

Keywords

FDG-PET CT, radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Progression free survival(PFS)

    • 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.

    2 years

Secondary Outcomes (6)

  • Locoregional control (LRC)

    2 years

  • Overall survival (OS)

    2 years

  • Second-line salvage therapy-free survival

    2 years

  • Acute radiation toxicity

    2 years

  • Late radiation toxicity

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Radiotherapy

EXPERIMENTAL

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.

Radiation: Radiotherapy

Observation

NO INTERVENTION

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.

Interventions

RadiotherapyRADIATION

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

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tata Memorial Centre

Mumbai, Maharashtra, 410210, India

NOT YET RECRUITING

Dr Vedang Murthy

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

MeSH Terms

Conditions

Seminoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

GerminomaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 3, 2021

Study Start

December 1, 2021

Primary Completion (Estimated)

December 15, 2029

Study Completion (Estimated)

December 15, 2029

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(2)