Actively Recruiting
THERApy De-escalation for TESTicular Cancer Observational Study of De-escalated and Standard Treatments for Stage II Seminoma
Led by Queen Mary University of London · Updated on 2026-03-02
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect data from 30 male patients aged 16 years and older who have stage II seminoma, a type of testicular cancer. It evaluates different treatment strategies, including standard of care and de-escalated treatments, to understand their impact on cancer and quality of life. The study is a feasibility observational cohort designed to help plan larger trials by assessing recruitment willingness and treatment effects over about three years. Patients are assigned to one of two treatment groups based on their eligibility and institutional practices. One group undergoes retroperitoneal lymph node dissection rRPLND surgery followed by further treatment or monitoring depending on surgical findings. The other group receives Carboplatin AUC10 chemotherapy. Those not eligible for or declining these treatments may receive other chemotherapy regimens or radiotherapy. All treatments follow shared decision-making between patients and clinicians. Participants are monitored for up to two years after treatment ends or until withdrawal or death. The study includes regular evaluations of quality of life through questionnaires, cancer progression, survival rates, and treatment safety. Data collected will help inform future larger studies and patient care strategies. After the study, patients continue their care according to institutional protocols.
CONDITIONS
Brief Title
THERApy De-escalation for TESTicular Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 16 years or older
- Histologically confirmed seminoma (biopsy or orchidectomy)
- Clinical stage II seminoma based on standard imaging
- Willing and able to provide written informed consent
- Able to comply with study procedures including completing questionnaires
- For rRPLND group: stage IIA or <3cm IIB with unifocal ipsilateral lymph node, negative or mildly elevated tumour markers, fit for surgery with BMI <34, low comorbidity, good performance status, no significant cardio-pulmonary disease, and no previous open intra-abdominal surgery
- For Carboplatin AUC10 group: meet IGCCCG good risk tumour marker criteria, glomerular filtration rate over 25 ml/min, performance status 0-2, and agree to use contraception or be sterile during therapy
You will not qualify if you...
- Raised AFP above 10ng/ml that does not lower after orchidectomy
- Previous chemotherapy or radiotherapy for this disease
- Previous or concurrent cancers other than testicular cancer unless treated curatively and no active disease for at least 2 years
- Any medical condition that could interfere with study evaluation or safety, including comorbidities affecting quality of life or adherence to study requirements
Research Team
T
Theratest study coordinator
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