De-escalation treatments for stage II seminoma

THERApy De-escalation for TESTicular Cancer

This study is testing whether less intense treatments for stage II seminoma can help patients feel better and manage their cancer just as well as standard treatments.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 16 Years and up
• Sex: Male
• Sponsor: Queen Mary University of London (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (London)
• Trial ID: NCT06309745 on ClinicalTrials.gov

What this trial studies

THERATEST is an observational study collecting data from patients with stage II seminoma receiving either standard of care treatments or de-escalation treatments in two UK hospitals. The study aims to assess patient willingness to participate, the effects of de-escalation treatments on cancer progression and quality of life, and to gather insights that could inform larger future studies. Patients will be categorized into cohorts based on their treatment options, including retroperitoneal lymph node dissection (rRPLND) or Carboplatin AUC10. The findings will help bridge knowledge gaps and guide the design of more extensive trials.

Who should consider this trial

Good fit: Ideal candidates are males aged 16 and older with histologically confirmed stage II seminoma.

Not a fit: Patients with advanced seminoma or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with stage II seminoma.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in optimizing treatment strategies for cancer patients.

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.
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 \<3cm IIB with unifocal ipsilateral lymph node within rRPLND template.
2. Negative or mildly elevated serum tumour markers, defined as:

   1. AFP (alpha-fetoprotein) \<10ng/ml and non-rising on serial testing
   2. BhCG (human chorionic gonadotropin) \<50mg/ml
   3. LDH (lactate dehydrogenase) \<1.5x upper limit normal
3. Fit for surgery, defined as meeting all of the following criteria:

   1. Body mass index (BMI) \<34
   2. Charlson comorbidity index ≤3
   3. ECOG Performance status 0-1
   4. No significant cardio-pulmonary disease, or other uncontrolled intercurrent illness that would limit fitness for surgery in the opinion of the investigator
   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. AFP \<10ng/ml
   2. any BhCG
   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:

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 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

Where this trial is running

London

• Barts and London Hospital NHS Trust — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Prabhakar Rajan — Queen Mary University of London
• Study coordinator: Theratest study coordinator

Conditions: Seminoma