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(PROSem) - PROSem

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/038265

Enrollment

Registered

2021-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C629- Malignant neoplasm of testis, unspecified whether descended or undescended

Interventions

Intervention1: Radiation therapy: 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. Control In

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To compare the 2 year progression-free survival(PFS) between the two arms Timepoint: 2 years	—

Secondary

Measure	Time frame
To compare the Acute radiation toxicity between the two armsTimepoint: 2 years;To compare the Late radiation toxicity between the two armsTimepoint: 2 years;To compare the Locoregional control (LRC)between the two armsTimepoint: 2 years;To compare the Overall survival (OS) between the two arms.Timepoint: 2 years;To compare the Patient-reported quality of life (QOL) between the two armsTimepoint: 2 years;To compare the Second-line salvage therapy-free survival between the two armsTimepoint: 2 years	—

Measure

Time frame

To compare the Acute radiation toxicity between the two armsTimepoint: 2 years;To compare the Late radiation toxicity between the two armsTimepoint: 2 years;To compare the Locoregional control (LRC)between the two armsTimepoint: 2 years;To compare the Overall survival (OS) between the two arms.Timepoint: 2 years;To compare the Patient-reported quality of life (QOL) between the two armsTimepoint: 2 years;To compare the Second-line salvage therapy-free survival between the two armsTimepoint: 2 years

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Countries

India

Contacts

Public ContactDr Vedang Murthy

Advanced Centre for Treatment, Research and Education for Cancer (ACTREC), Tata Memorial Centre

vedangmurthy@gmail.com022-27405160

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026