THERApy De-escalation for TESTicular Cancer
ConditionSeminoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age16+
SponsorQueen Mary University of London
About this trial
THERATEST is looking to collect data from 30 patients actively receiving de-escalation treatments or other standard of care treatments in two UK hospitals. THERATEST is a feasibility study to determine whether patients are willing to be recruited, the impact of de-escalation treatments on patients' cancers and quality of life, whether we should proceed with these treatments in a larger study, and if so how the study should be conducted. A feasibility study prepares the ground for a larger study and improves the chances of the subsequent study producing valuable evidence, and helps to avoid wasting precious resources on larger trials that are unlikely to be informative. We hope that information from THERATEST will bridge the current knowledge gap and allow clinicians to design bigger trials to actively compare the different treatment strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide written informed consent.
Male.
Age ≥ 16 years.
Histologically confirmed seminoma (biopsy/orchidectomy)
Disqualifiers
Raised AFP > 10ng/ml that does not fall to <10ng/ml following orchidectomy
Previous chemotherapy or radiotherapy for the disease under study.
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).
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
retroperitoneal lymph node dissection
Procedure/Surgeryretroperitoneal lymph node dissection
Carboplatin AUC10
DrugCarboplatin AUC10
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: RPLND cohort1 intervention
Group B: Carboplatin AUC10 cohort1 intervention
Trial outcomes
Primary outcomes
1
FEASIBILITY of recruitment and retention
To demonstrate feasibility of recruitment and retention (number of participants recruited per month and retained annually). Completion of recruitment of 30 patients into the THERATEST study, and measurement of overall patient retention within the trial until the 2-year follow-up visit.
Time frame
through study completion, an average of 3 yearSecondary outcomes
1
QUALITY OF LIFE assessed by difference in HRQOL scores
To determine differences in Health-related QOL (HRQOL) before and after treatment(s). Change in domain scale scores/single item scores in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-TC26 and EORTC QLQ-C30, measured from baseline until the 2-year follow-up visit.
Time frame
through study completion, an average of 3 year2
QUALITY OF LIFE assessed by difference in differences in sexual drive, function, and overall satisfaction
To determine differences in sexual drive, function, and overall satisfaction before and after treatment(s). Change in domain scale scores/single item scores in Brief Male Sexual Function Inventory (BMSFI), QLQ-TC26, and supplementary questions on retrograde ejaculation. Measured from baseline until the 2-year follow-up visit.
Time frame
through study completion, an average of 3 year3
Progression free SURVIVAL
• To determine progression-free survival (PFS) and overall survival (OS) rates ensuring these fall in line with standard of care treatments outcomes (\>95%). PFS rate at 2 years, defined as the proportion of patients who did not experience disease progression or death from any cause during the 2-year follow-up period.
Time frame
through study completion, an average of 3 year4
OVERALL SURVIVAL
• To determine progression-free survival (PFS) and overall survival (OS) rates ensuring these fall in line with standard of care treatments outcomes (\>95%). OS rate at 2 years, defined as the proportion of patients who did not experience death from any cause during the 2-year follow-up period.
Time frame
through study completion, an average of 3 yearSponsors and contacts
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Source ClinicalTrials.gov