ISRCTN61007118
Active, not recruiting
未知
THERApy de-escalation for TESTicular cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Queen Mary University of London
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- •1\. Willing and able to provide written informed consent
- •3\. Age \= 16 years
- •4\. Histologically confirmed seminoma (biopsy/orchidectomy)
- •5\. Clinical stage II (standard of care cross\-sectional imaging)
- •6\. Ability to comply with the protocol, including but not limited to, completion of the patient\-reported outcome questionnaires. rRPLND cohort\-specific inclusion criteria
- •Participants must meet the following additional inclusion criteria to register for the rRPLND cohort:
- •1\. Stage IIA and \<3cm IIB with unifocal ipsilateral lymph node within rRPLND template.
- •2\. Negative or mildly elevated serum tumour markers, defined as:
- •2\.1\. AFP (alpha\-fetoprotein) \<10ng/ml and non\-rising on serial testing
Exclusion Criteria
- •A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- •1\. Raised AFP \> 10ng/ml that does not fall to \<10ng/ml following orchidectomy
- •2\. Previous chemotherapy or radiotherapy for the disease under study.
- •3\. 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).
- •4\. Any condition that, in the opinion of the investigator, would interfere with the 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.
Outcomes
Primary Outcomes
Not specified
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