Radiotherapy Vs Observation for post chemotherapy residual mass in advanced Seminoma
Phase 3
- Conditions
- Health Condition 1: C629- Malignant neoplasm of testis, unspecified whether descended or undescended
- Registration Number
- CTRI/2021/11/038265
- Lead Sponsor
- Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the 2 year progression-free survival(PFS) between the two arms <br/ ><br> <br/ ><br>Timepoint: 2 years <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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