Testicular CancerPhase 2RPLND-SeminomaNCT06932458
A Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
A Phase 2 study testing Retroperitoneal Lymph Node Dissection in people with Testicular Cancer, run by Western University, Canada at 1 site in Canada.
Trial summary
Testicular cancer represents 1% of adult neoplasms and is the most common solid malignancy in young men. At diagnosis, approximately 90% of cases are germ cell tumours (GCT), categorised as either seminoma (55-60%) or non-seminoma types (40-45%). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Retroperitoneal Lymph Node Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jul 2025to 1 Jun 2030
- Phase
- Phase 2
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years) with pure seminoma on radical orchiectomy specimen.
- Initial CS I presentation with subsequent retroperitoneal relapse on surveillance, or de novo CS II at presentation.
- Axial imaging of lymphadenopathy within 8 weeks of the date of RPLND
- No more than 2 enlarged retroperitoneal lymph nodes, each no more than 3cm in the primary landing zones.
- Suitable for proposed bilateral RPLND template
- Serum tumour markers (alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), and lactate dehydrogenase (LDH)) must all be within normal limits within 2 weeks of planned RPLND
Who cannot join
- Any condition deemed by the treating surgeon to pose an unacceptable risk for retroperitoneal lymph node dissection
- Any non-seminoma component on the orchiectomy specimen.
- AFP >20 at any time point, pre- or post-orchiectomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario
Kaydee Connors, 519-685-8500 ext. 56366, Kaydee.Connors@lhsc.on.ca
About this study
Official title: A Phase II Single-arm Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
Testicular cancer represents 1% of adult neoplasms and is the most common solid malignancy in young men. At diagnosis, approximately 90% of cases are germ cell tumours (GCT), categorised as either seminoma (55-60%) or non-seminoma types (40-45%).
For many years, the management of patients with CS IIA/B seminoma and retroperitoneal lymph node involvement ≤ 3 cm are eligible for treatment with either radiotherapy or chemotherapy Despite high cure rates for CS II seminoma (approximately 90%) with chemotherapy or radiotherapy, concerns persist regarding short and long-term treatment-related toxicities (such as increased risks of cardiovascular disease and secondary malignancies As such, an alternative strategy which has been explored in this study is the role of RPLND for the management of these patients
Read the detailed description
Testicular cancer represents 1% of adult neoplasms and is the most common solid malignancy in young men. At diagnosis, approximately 90% of cases are germ cell tumours (GCT), categorised as either seminoma (55-60%) or non-seminoma types (40-45%). Approximately 20% of men with seminoma present with clinical stage (CS) II disease, characterized by enlarged retroperitoneal lymph nodes without distant metastasis.
For many decades for patients who recur following CS 1 seminoma or present with de novo CS IIA/B seminoma, either radiotherapy (30-36Gy) or chemotherapy (BEPx3, EPx4) has been the mainstay of treatment. Yet, both treatment paradigms carry significant short and long-term treatment-related toxicities. Radiotherapy, when compared to surveillance or surgery alone, has been shown to double the risk of cardiovascular disease and secondary malignancies (with an incidence of 2-3%). Additionally, patients who receive chemotherapy for GCTs can develop complications including irreversible neurotoxicity (10%), ototoxicity (5-12%), pulmonary toxicity, which may result in permanent restrictive lung disease (8%), metabolic syndrome (10-16%), and hypogonadism (4%). Additionally, patients are at an approximate 3-7-fold increase in cardiovascular mortality and a two-fold increase in secondary solid malignancies and leukaemia. Furthermore, both treatment modalities can harm fertility potential by approximately 20-30%.
However, in the past few years, a number of prospective single arm studies have been published evaluating the role of RPLND. RPLND is an appealing choice for patients with low-volume metastatic seminoma for several reasons: Firstly, seminoma exhibits a more indolent biological behaviour and a predictable lymphatic spread pattern compared to non-seminoma diseases, potentially allowing a greater chance of cure with surgery alone. Secondly, RPLND enables precise pathological staging which can avoid overtreatment in those with pathologically negative lymph nodes. It offers an opportunity to reduce the burden of chemotherapy by reserving this treatment only for the small proportion of men who will relapse following RPLND. Finally, RPLND offers an acceptably low risk of short or long-term complications when performed at experienced centres.
Therefore, our objective is to prospectively evaluate the short and long-term safety and efficacy of Primary Retroperitoneal Lymph Node Dissection (RPLND) for patients with testicular seminoma and limited retroperitoneal lymph node metastasis.
- Conditions
- Testicular Cancer
- Being tested
- Retroperitoneal Lymph Node Dissection
- Keywords
- Seminoma, Retroperitoneal lymph node dissection
- Medical subject headings
- Testicular Neoplasms, Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroperitoneal Lymph Node DissectionProcedure or surgery
Open bilateral nerve-sparing RPLND.
| Study group | Role | What they receive |
|---|---|---|
| CS IIA/IIB Seminoma | Other | Patients with relapsed CS I or de novo CS IIA/B with <3cm lymph node in the retroperitoneal lymph node. Receives: Procedure: Retroperitoneal Lymph Node Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival
2-year RFS (absence of radiological metastases on cross-sectional imaging and normal serum tumour markers).
Measured: 2 years
Secondary outcomes (5)
Complications
Complications post RPLND (Clavein-Dindo)
Measured: 90 days
Length of Stay in hospital
Length of stay in hospital post RPLND
Measured: 90 days
Treatment-Free Survival
Patients avoiding additional treatments for seminoma post RPLND (e.g. chemotherapy / radiotherapy)
Measured: 24 months
Cancer-specific Survival
Percentage of people who have not died from testicular cancer during follow-up
Measured: 24 months
Overall Survival
Patients alive during follow-up
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 posted17 Apr 2025
- Study start17 Jul 2025 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932458
- Sponsor's protocol ID
- 126353
- Acronym
- RPLND-Seminoma
- Status last verified
- Jul 2025
- First submitted
- 9 Apr 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fung C, Dinh P Jr, Ardeshir-Rouhani-Fard S, Schaffer K, Fossa SD, Travis LB. Toxicities Associated with Cisplatin-Based Chemotherapy and Radiotherapy in Long-Term Testicular Cancer Survivors. Adv Urol. 2018 Feb 18;2018:8671832. doi: 10.1155/2018/8671832. eCollection 2018.
PubMed 29670654Fossa SD, Dahl AA, Thorsen L, Hellesnes R, Kiserud CE, Tandstad T, Brydoy M, Haugnes HS, Myklebust TA. Mortality and Second Cancer Incidence After Treatment for Testicular Cancer: Psychosocial Health and Lifestyle Are Modifiable Prognostic Factors. J Clin Oncol. 2022 Aug 10;40(23):2588-2599. doi: 10.1200/JCO.21.02105. Epub 2022 Apr 5.
PubMed 35380874Hamilton RJ, Canil C, Shrem NS, Kuhathaas K, Jiang MD, Chung P, North S, Czaykowski P, Hotte S, Winquist E, Kollmannsberger C, Aprikian A, Soulieres D, Tyldesley S, So AI, Power N, Rendon RA, O'Malley M, Wood L. Canadian Urological Association consensus guideline: Management of testicular germ cell cancer. Can Urol Assoc J. 2022 Jun;16(6):155-173. doi: 10.5489/cuaj.7945. No abstract available.
PubMed 35623007
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-arm Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
- ClinicalTrials.gov ID
- NCT06932458
- Acronym / sponsor ID
- RPLND-Seminoma / 126353
- Conditions
- Testicular Cancer
- Keywords
- Seminoma, Retroperitoneal lymph node dissection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 17 Jul 2025 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 17 Apr 2025 (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 cancer represents 1% of adult neoplasms and is the most common solid malignancy in young men. At diagnosis, approximately 90% of cases are germ cell tumours (GCT), categorised as either seminoma (55-60%) or non-seminoma types (40-45%).
For many years, the management of patients with CS IIA/B seminoma and retroperitoneal lymph node involvement ≤ 3 cm are eligible for treatment with either radiotherapy or chemotherapy Despite high cure rates for CS II seminoma (approximately 90%) with chemotherapy or radiotherapy, concerns persist regarding short and long-term treatment-related toxicities (such as increased risks of cardiovascular disease and secondary malignancies As such, an alternative strategy which has been explored in this study is the role of RPLND for the management of these patients
Detailed description
Testicular cancer represents 1% of adult neoplasms and is the most common solid malignancy in young men. At diagnosis, approximately 90% of cases are germ cell tumours (GCT), categorised as either seminoma (55-60%) or non-seminoma types (40-45%). Approximately 20% of men with seminoma present with clinical stage (CS) II disease, characterized by enlarged retroperitoneal lymph nodes without distant metastasis.
For many decades for patients who recur following CS 1 seminoma or present with de novo CS IIA/B seminoma, either radiotherapy (30-36Gy) or chemotherapy (BEPx3, EPx4) has been the mainstay of treatment. Yet, both treatment paradigms carry significant short and long-term treatment-related toxicities. Radiotherapy, when compared to surveillance or surgery alone, has been shown to double the risk of cardiovascular disease and secondary malignancies (with an incidence of 2-3%). Additionally, patients who receive chemotherapy for GCTs can develop complications including irreversible neurotoxicity (10%), ototoxicity (5-12%), pulmonary toxicity, which may result in permanent restrictive lung disease (8%), metabolic syndrome (10-16%), and hypogonadism (4%). Additionally, patients are at an approximate 3-7-fold increase in cardiovascular mortality and a two-fold increase in secondary solid malignancies and leukaemia. Furthermore, both treatment modalities can harm fertility potential by approximately 20-30%.
However, in the past few years, a number of prospective single arm studies have been published evaluating the role of RPLND. RPLND is an appealing choice for patients with low-volume metastatic seminoma for several reasons: Firstly, seminoma exhibits a more indolent biological behaviour and a predictable lymphatic spread pattern compared to non-seminoma diseases, potentially allowing a greater chance of cure with surgery alone. Secondly, RPLND enables precise pathological staging which can avoid overtreatment in those with pathologically negative lymph nodes. It offers an opportunity to reduce the burden of chemotherapy by reserving this treatment only for the small proportion of men who will relapse following RPLND. Finally, RPLND offers an acceptably low risk of short or long-term complications when performed at experienced centres.
Therefore, our objective is to prospectively evaluate the short and long-term safety and efficacy of Primary Retroperitoneal Lymph Node Dissection (RPLND) for patients with testicular seminoma and limited retroperitoneal lymph node metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS IIA/IIB Seminoma | Other | Procedure: Retroperitoneal Lymph Node DissectionPatients with relapsed CS I or de novo CS IIA/B with <3cm lymph node in the retroperitoneal lymph node. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (>18 years) with pure seminoma on radical orchiectomy specimen.
- Initial CS I presentation with subsequent retroperitoneal relapse on surveillance, or de novo CS II at presentation.
- Axial imaging of lymphadenopathy within 8 weeks of the date of RPLND
- Serum tumour markers (alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), and lactate dehydrogenase (LDH)) must all be within normal limits within 2 weeks of planned RPLND
Key exclusion criteria (3 listed)
- Any condition deemed by the treating surgeon to pose an unacceptable risk for retroperitoneal lymph node dissection
- Any non-seminoma component on the orchiectomy specimen.
- AFP >20 at any time point, pre- or post-orchiectomy.
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 |
|---|---|---|
| Retroperitoneal Lymph Node DissectionOpen bilateral nerve-sparing RPLND. | Procedure or surgery | CS IIA/IIB Seminoma |
Primary outcome
Recurrence Free Survival
Time frame: 2 years
2-year RFS (absence of radiological metastases on cross-sectional imaging and normal serum tumour markers).
5 secondary outcomes
Complications
Time frame: 90 days
Length of Stay in hospital
Time frame: 90 days
Treatment-Free Survival
Time frame: 24 months
Cancer-specific Survival
Time frame: 24 months
Overall Survival
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 20 Jul 2025.
- Background: PubMed 29670654Fung C, Dinh P Jr, Ardeshir-Rouhani-Fard S, Schaffer K, Fossa SD, Travis LB. Toxicities Associated with Cisplatin-Based Chemotherapy and Radiotherapy in Long-Term Testicular Cancer Survivors. Adv Urol. 2018 Feb 18;2018:8671832. doi: 10.1155/2018/8671832. eCollection 2018.
- Background: PubMed 35380874Fossa SD, Dahl AA, Thorsen L, Hellesnes R, Kiserud CE, Tandstad T, Brydoy M, Haugnes HS, Myklebust TA. Mortality and Second Cancer Incidence After Treatment for Testicular Cancer: Psychosocial Health and Lifestyle Are Modifiable Prognostic Factors. J Clin Oncol. 2022 Aug 10;40(23):2588-2599. doi: 10.1200/JCO.21.02105. Epub 2022 Apr 5.
- Background: PubMed 35623007Hamilton RJ, Canil C, Shrem NS, Kuhathaas K, Jiang MD, Chung P, North S, Czaykowski P, Hotte S, Winquist E, Kollmannsberger C, Aprikian A, Soulieres D, Tyldesley S, So AI, Power N, Rendon RA, O'Malley M, Wood L. Canadian Urological Association consensus guideline: Management of testicular germ cell cancer. Can Urol Assoc J. 2022 Jun;16(6):155-173. doi: 10.5489/cuaj.7945. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Retroperitoneal Lymph Node Dissection in people with Testicular Cancer, run by Western University, Canada at 1 site in Canada.
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 6 inclusion and 3 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Kaydee Connors (519-685-8500 ext. 56366, Kaydee.Connors@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06932458, which also lists 3 linked publications.
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 20 Jul 2025.