SeminomaNCT05142982
Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma
A study testing Radiotherapy in people with Seminoma, run by Tata Memorial Centre at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Seminoma
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Dec 2021to 15 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Not yet recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 410210
Vedang Murthy, vmurthy@actrec.gov.in
Gitanjali Panigrahi, 02224175000 ext. 5097, urooncorttrial@gmail.com
- Recruiting
Dr Vedang Murthy
Navi Mumbai, Maharashtra, 410210
Vedang Murthy, MD(Radiation Oncology), 022-2740500 ext. 5010, vmurthy@actrec.gov.in
Dr Vedang Murthy, MD(Radiation Oncology)
About this study
Official title: FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial
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.
- Conditions
- Seminoma
- Being tested
- Radiotherapy
- Keywords
- FDG-PET CT, radiotherapy
- Medical subject headings
- Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 years
Late radiation toxicity
Incidence of late radiation toxicity defined as any toxicity after 90 days of post RT using RTOG and CTCAE
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Dec 2021
- Primary completion15 Dec 2029 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeminomaStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vedang Murthy, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142982
- Sponsor's protocol ID
- PROsem
- Status last verified
- Feb 2025
- First submitted
- 15 Nov 2021
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05142982
- Acronym / sponsor ID
- PROsem
- Conditions
- Seminoma
- Keywords
- FDG-PET CT, radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Dec 2029 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: RadiotherapyPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyA 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 |
Primary outcome
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.
6 secondary outcomes
Locoregional control (LRC)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Second-line salvage therapy-free survival
Time frame: 2 years
Acute radiation toxicity
Time frame: 2 years
Late radiation toxicity
Time frame: 2 years
Patient-reported quality of life (QOL)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Seminoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with Seminoma, run by Tata Memorial Centre at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival(PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.