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NCT Number: NCT05142982

Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

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.

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Key information

Conditions

Seminoma Germinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tata Memorial Centre, Mumbai, Maharashtra, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

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.

Primary outcomes

  1. Progression free survival(PFS)

    Time frame: 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.

Secondary outcomes

  1. Locoregional control (LRC)

    Time frame: 2 years

    • Locoregional control (LRC) defined as the time period from the date of enrolment in the study till the first observation of disease progression locally and/or in the regional lymph nodes, or death.

  2. Overall survival (OS)

    Time frame: 2 years

    • Overall survival (OS) defined as the time period from the date of enrolment in the study till the date of death.

  3. Second-line salvage therapy-free survival

    Time frame: 2 years

    • Second-line salvage therapy-free survival defined as the time period from the date of enrolment in the study till date of starting second-line chemotherapy.

  4. Acute radiation toxicity

    Time frame: 2 years

    Incidence of Acute radiation toxicity will be defined as any toxicity within 90 days post RT using RTOG and CTCAE

  5. Late radiation toxicity

    Time frame: 2 years

    Incidence of late radiation toxicity defined as any toxicity after 90 days of post RT using RTOG and CTCAE

  6. Patient-reported quality of life (QOL)

    Time frame: 2 years

    Patient-reported quality of life (QOL) will be assessed using the EORTC QLQ-C30 questionnaire's validated translations in English, Hindi, and Marathi.

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Official study title

FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Dec 3, 2021
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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