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Testicular cancer patients needed for landmark treatment reduction study

NCT ID NCT06309745

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

16 years and older

Sex

Male participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Barts and London Hospital NHS Trust

    RECRUITING

    London, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.