Testicular cancer patients needed for landmark treatment reduction study
NCT ID NCT06309745
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether giving less treatment (de-escalation) to men with stage II seminoma testicular cancer is safe and improves quality of life. Researchers will enroll 30 men at two UK hospitals to see if patients are willing to join and how their cancer and well-being are affected. The goal is to gather information needed to design a larger, more definitive trial.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A. rRPLND cohort: Patients with seminoma who are negative/low for tumour markers and unifocal ipsilateral Stage IIA or \<3cm IIB will be assessed for rRPLND. Patients who are eligible for rRPLND will undergo surgery followed by adjuvant treatment or surveillance as determined by their clinical teams based on post-operative histology as per SOC. Patients who are not deemed eligible for or decline rRPLND, will be offered either BEP/EP chemotherapy or radiotherapy with or without neoadjuvant Carboplatin AUC7 and will continue to be followed in the study. B. Carboplatin AUC10 cohort: Patients with stage II seminoma will be offered Carboplatin AUC10. Those deemed ineligible for Carboplatin AUC10 or who decline this treatment option will be offered either BEP/EP chemotherapy or radiotherapy and will continue to be followed in the study.
- Ages
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16 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Willing and able to provide written informed consent. 2. Male. 3. Age ≥ 16 years. 4. Histologically confirmed seminoma (biopsy/orchidectomy) 5. Clinical stage II (standard of care cross-sectional imaging). 6. Ability to comply with the protocol, including but not limited to, completion of the patient-reported outcome questionnaires. rRPLND cohort specific inclusion criteria Participants must meet the following additional inclusion criteria to register for the rRPLND cohort: 1. Stage IIA and \<3cm IIB with unifocal ipsilateral lymph node within rRPLND template. 2. Negative or mildly elevated serum tumour markers, defined as: 1. AFP (alpha-fetoprotein) \<10ng/ml and non-rising on serial testing 2. BhCG (human chorionic gonadotropin) \<50mg/ml 3. LDH (lactate dehydrogenase) \<1.5x upper limit normal 3. Fit for surgery, defined as meeting all of the following criteria: 1. Body mass index (BMI) \<34 2. Charlson comorbidity index ≤3 3. ECOG Performance status 0-1 4. No significant cardio-pulmonary disease, or other uncontrolled intercurrent illness that would limit fitness for surgery in the opinion of the investigator 5. No previous open intra-abdominal surgery Carboplatin AUC10 cohort specific inclusion criteria Participants must meet the following additional inclusion criteria to register for the Carboplatin AUC10 group: 1. Serum tumour markers, defined by IGCCCG "good risk" criteria: 1. AFP \<10ng/ml 2. any BhCG 3. LDH \<2.5x ULN 2. Glomerular filtration rate by EDTA clearance over 25 ml/min (a measured creatinine clearance using Cockcroft and Gault would be allowed if unable to perform EDTA clearance). 3. ECOG Performance status 0-2. 4. Patients must be sterile or agree to use adequate contraception during the period of therapy. Exclusion Criteria: 1. Raised AFP \> 10ng/ml that does not fall to \<10ng/ml following orchidectomy 2. Previous chemotherapy or radiotherapy for the disease under study. 3. Previous or concurrent malignancy other than testicular cancer, unless treated with curative intent and with no known active disease present for ≥2 years before enrolment and felt to be at low risk for recurrence by the treating physician (for example: non-melanoma skin cancer or lentigo maligna; breast ductal carcinoma in situ; prostatic intraepithelial neoplasia; urothelial papillary non-invasive carcinoma or urothelial carcinoma in situ). 4. Any condition that, in the opinion of the investigator, would interfere with evaluation of study intervention or interpretation of patient safety or study results such as medical comorbidities impacting on QoL or medical conditions or other disorders that would affect adherence to study requirements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Barts and London Hospital NHS Trust
RECRUITINGLondon, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- High-Dose chemo with stem cell transplant tested against standard therapy for tough germ cell cancers
- New proton beam study aims to cut cancer treatment side effects
- Testicular cancer treatment: which is easier on patients?
- Blood marker may predict cancer return in testicular tumor patients
- Immunotherapy duo takes on resistant germ cell tumors