Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309745
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-09-08
Brief Title:
THERApy De-escalation for TESTicular Cancer
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
THERApy De-escalation for TESTicular Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THERATEST
Brief Summary:
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
Detailed Description:
THERATEST is an observational cohort study of patients receiving SOC treatments combination chemotherapy or radiotherapy or de-escalated treatments primary rRPLND or Carboplatin AUC10 treatments for stage II seminoma
Potential patients will be identified and invited to join the THERATEST study Patients will be allocated to the following cohorts based on whether the relevant mode of treatment is adopted as an institutional SOC in their respective institution
A rRPLND cohort Patients with seminoma who are negativelow 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 BEPEP 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 BEPEP chemotherapy or radiotherapy and will continue to be followed in the study
Chemotherapy treatment strategies and adjuvant treatments are left to the shared decision-making between treating clinician and patient and follow institutional SOC In both cohorts patients will be followed up for 2 years after treatment completion or until death or withdrawal of consent whichever is the earliest Beyond the study period patients will be follow up as per institutional SOC protocols as part of prospective institutional audits
Potential patients will be identified and invited to join the THERATEST study Patients will be allocated to the following cohorts based on whether the relevant mode of treatment is adopted as an institutional SOC in their respective institution
A rRPLND cohort Patients with seminoma who are negativelow 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 BEPEP 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 BEPEP chemotherapy or radiotherapy and will continue to be followed in the study
Chemotherapy treatment strategies and adjuvant treatments are left to the shared decision-making between treating clinician and patient and follow institutional SOC In both cohorts patients will be followed up for 2 years after treatment completion or until death or withdrawal of consent whichever is the earliest Beyond the study period patients will be follow up as per institutional SOC protocols as part of prospective institutional audits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None