Patients with testicular seminoma who are negative/low for tumour markers and unifocal ipsilateral Stage IIA or <3 cm IIB will be assessed for robot-assisted retroperitoneal lymph node dissection (rRPLND) Cancer
Conditions
Interventions
THERATEST is an observational cohort study of patients receiving standard-of-care (SOC) treatments (combination chemotherapy or radiotherapy) or de-escalated treatments (primary rRPLND or Carboplatin
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
Male
Age
16 Years to 100 Years
Inclusion 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 2. Male 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 <3 cm IIB with unifocal ipsilateral lymph node within rRPLND template. 2. Negative or mildly elevated serum tumour markers, defined as: 2.1. AFP (alpha-fetoprotein) <10 ng/ml and non-rising on serial testing 2.2. BhCG (human chorionic gonadotropin) <50 mg/ml 2.3. LDH (lactate dehydrogenase) <1.5x upper limit normal 3. Fit for surgery, defined as meeting all of the following criteria: 3.1. Body mass index (BMI) <34 3.2. Charlson comorbidity index =3 3.3. ECOG Performance status 0-1 3.4. No significant cardio-pulmonary disease, or other uncontrolled intercurrent illness that would limit fitness for surgery in the opinion of the investigator 3.5. No previous open intra-abdominal surgery Carboplatin AUC10 cohort-specific inclusion criteria Participants must meet the following additional inclusion criteria to register for the Carboplatin AUC10 group: 1. Serum tumour markers, defined by IGCCCG “good risk” criteria: 1.1. AFP <10 ng/ml 1.2. any BhCG 1.3. LDH <2.5x ULN 2. Glomerular filtration rate by EDTA clearance over 25 ml/min (a measured creatinine clearance using Cockcroft and Gault would be allowed if unable to perform EDTA clearance) 3. ECOG Performance status 0-2 4. Patients must be sterile or agree to use adequate contraception during the period of therapy
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility will be measured using recruitment and retention (number of participants recruited per month and retained annually) data collected from the patient visits and recorded within the study electronic database at one time point | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life measured using the change in domain scale scores/single item scores in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-TC26 and EORTC QLQ-C30 before and after treatment(s) 2. Sexual drive, function, and overall satisfaction measured using the change in domain scale scores/single item scores in Brief Male Sexual Function Inventory (BMSFI), QLQ-TC26, and supplementary questions on retrograde ejaculation before and after treatment(s) 3. Progression-free survival (PFS) and overall survival (OS) rates to ensure these fall in line with standard-of-care treatment 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. 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.] 4. Safety and complications of all treatments measured using the incidence, nature and severity of adverse events with severity determined according to CTCAE v5.0 collected from consent until 6 weeks post-surgery or chemotherapy. Surgical complications will be assessed by the Clavien-Dindo scoring system, and analysing details of surgical complications, blood transfusion, ITU admission and dialysis rates from patient records up to 6 months post-rRPLND. | — |
Countries
England, United Kingdom
Contacts
Public ContactPrabhakar Rajan
Outcome results
None listed