[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539892":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Queen Mary University of London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RPLND cohort",null,"Patients with seminoma who are negative\u002Flow for tumour markers and unifocal ipsilateral Stage IIA or \\\u003C3cm 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\u002FEP chemotherapy or radiotherapy with or without neoadjuvant Carboplatin AUC7 and will continue to be followed in the study.",[13],"Procedure: retroperitoneal lymph node dissection",{"label":15,"type":10,"description":16,"interventionNames":17},"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\u002FEP chemotherapy or radiotherapy and will continue to be followed in the study.",[18],"Drug: Carboplatin AUC10",[20,24],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","retroperitoneal lymph node dissection",[9],{"type":25,"name":26,"description":26,"armGroupLabels":27,"otherNames":10},"DRUG","Carboplatin AUC10",[15],[29],{"name":30,"affiliation":5,"role":31},"Prabhakar Rajan","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Theratest study coordinator","CONTACT","020 7882 8478","bci-theratest@qmul.ac.uk",[39],{"facility":40,"status":41,"city":42,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Barts and London Hospital NHS Trust","RECRUITING","London","United Kingdom","UK",{"type":46,"coordinates":47},"Point",[48,49],-0.12574,51.50853,{"lat":49,"lon":48},[52],{"name":53,"role":35,"phone":10,"phoneExt":10,"email":10},"THERATEST Study coordinator",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100539892","therapy-de-escalation-for-testicular-cancer-100539892",false,"NCT06309745","THERApy De-escalation for TESTicular Cancer","THERATEST","Inclusion Criteria:\n\nEach patient must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Willing and able to provide written informed consent.\n2. Male.\n3. Age ≥ 16 years.\n4. Histologically confirmed seminoma (biopsy\u002Forchidectomy)\n5. Clinical stage II (standard of care cross-sectional imaging).\n6. Ability to comply with the protocol, including but not limited to, completion of the patient-reported outcome questionnaires.\n\nrRPLND cohort specific inclusion criteria\n\nParticipants must meet the following additional inclusion criteria to register for the rRPLND cohort:\n\n1. Stage IIA and \\\u003C3cm IIB with unifocal ipsilateral lymph node within rRPLND template.\n2. Negative or mildly elevated serum tumour markers, defined as:\n\n   1. AFP (alpha-fetoprotein) \\\u003C10ng\u002Fml and non-rising on serial testing\n   2. BhCG (human chorionic gonadotropin) \\\u003C50mg\u002Fml\n   3. LDH (lactate dehydrogenase) \\\u003C1.5x upper limit normal\n3. Fit for surgery, defined as meeting all of the following criteria:\n\n   1. Body mass index (BMI) \\\u003C34\n   2. Charlson comorbidity index ≤3\n   3. ECOG Performance status 0-1\n   4. No significant cardio-pulmonary disease, or other uncontrolled intercurrent illness that would limit fitness for surgery in the opinion of the investigator\n   5. No previous open intra-abdominal surgery\n\nCarboplatin AUC10 cohort specific inclusion criteria\n\nParticipants must meet the following additional inclusion criteria to register for the Carboplatin AUC10 group:\n\n1. Serum tumour markers, defined by IGCCCG \"good risk\" criteria:\n\n   1. AFP \\\u003C10ng\u002Fml\n   2. any BhCG\n   3. LDH \\\u003C2.5x ULN\n2. Glomerular filtration rate by EDTA clearance over 25 ml\u002Fmin (a measured creatinine clearance using Cockcroft and Gault would be allowed if unable to perform EDTA clearance).\n3. ECOG Performance status 0-2.\n4. Patients must be sterile or agree to use adequate contraception during the period of therapy.\n\nExclusion Criteria:\n\n1. Raised AFP \\> 10ng\u002Fml that does not fall to \\\u003C10ng\u002Fml following orchidectomy\n2. Previous chemotherapy or radiotherapy for the disease under study.\n3. 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).\n4. 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","MALE","16 Years",{"count":66,"type":67},30,"ESTIMATED","OBSERVATIONAL","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.",[71],"Seminoma","2026-02-26",{"date":74,"type":75},"2026-03-02","ACTUAL",{"date":77,"type":75},"2024-06-24",{"date":79,"type":67},"2028-10-02",{"name":5,"class":6},1]