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
Qualifiers
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 design
Treatments tested in this trial
- retroperitoneal lymph node dissection
- Carboplatin AUC10
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov