An interventional study of Radiotherapy in Seminoma, sponsored by Tata Memorial Centre. Recruiting at 2 sites in India. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Tata Memorial Centre · Not applicable, Interventional, and Treatment
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.
63 studies on the registry are indexed under Seminoma; 15 are open to participants now.
This study's planned enrollment of 74 is above the median of 50 across 47 interventional studies indexed under Seminoma.
Browse Seminoma studies →Tata Memorial Centre is the lead sponsor of 64 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 2 years
Locoregional control (LRC)
• 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.
Time frame: 2 years
Overall survival (OS)
• Overall survival (OS) defined as the time period from the date of enrolment in the study till the date of death.
Time frame: 2 years
Second-line salvage therapy-free survival
• 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.
Time frame: 2 years
Acute radiation toxicity
Incidence of Acute radiation toxicity will be defined as any toxicity within 90 days post RT using RTOG and CTCAE
Time frame: 2 years
Late radiation toxicity
Incidence of late radiation toxicity defined as any toxicity after 90 days of post RT using RTOG and CTCAE
Time frame: 2 years
Patient-reported quality of life (QOL)
Patient-reported quality of life (QOL) will be assessed using the EORTC QLQ-C30 questionnaire's validated translations in English, Hindi, and Marathi.
Time frame: 2 years
Plan to share: No
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Tata Memorial Centre