SAKK 01/18: Reduced intensity radio-chemotherapy for Stage IIA/B seminoma. A multicenter, open label phase II trial with two cohorts

Swiss Group for Clinical Cancer Research9 sites in 1 country95 target enrollmentAugust 12, 2024

DrugsEtomedac 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung Carboplat onkovis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Swiss Group for Clinical Cancer Research
Enrollment: 95
Locations: 9
Primary Endpoint: Progression free survival (PFS) at 3 years
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To investigate efficacy of a stage-adapted treatment regimen in stage IIA/B seminoma based on the preliminary experience gained in SAKK 01/10

Registry

euclinicaltrials.eu

Start Date

August 12, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Swiss Group for Clinical Cancer Research

Responsible Party

Principal Investigator

Competence Center of SAKK

Scientific

Swiss Group for Clinical Cancer Research

Eligibility Criteria

Inclusion Criteria

•Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
•Adequate renal function: creatinine clearance ≥ 60 ml/min calculated according to the CKD-EPI formula
•Patient agrees to use highly effective contraception and not to donate sperm or to father a child during trial treatment and during 12 months thereafter. Patient has been proposed sperm conservation
•Histologically confirmed classical seminoma treated with primary inguinal orchidectomy or partial orchidectomy
•Patients with a seminoma stage IIA or IIB, either newly diagnosed or recurrent after primary active surveillance, adjuvant carboplatin or radiotherapy for stage I disease. The tumor stage is pT1-4 cN1-2 cM0 according to UICC TNM 8th edition
•Patients with a recurrent seminoma stage IIA or IIB are only eligible in case of progression under active surveillance or recurrence after adjuvant carboplatin or radiotherapy for stage I disease
•Stage IIA, in patients with equivocal lymph node enlargement, needs to be confirmed with a repeated CT/MRI scan of the abdomen (suggested timeframe: 4 weeks after the previous scan) in order to rule out false positive lymph node enlargement. Patients with a prior malignancy treated with curative intention are eligible if all treatment of that malignancy was completed at least 5 years before registration and the patient has no evidence of disease at registration. Less than 5 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence. Patients with a germ cell neoplasia in situ (GCNIS) or contralateral localized treated seminoma are eligible.
•Diagnostic CT or MRI or FDG-PET-CT of the chest, abdomen and pelvis within 28 days prior to registration, showing stage IIA/B disease. I.v. contrast medium has to be administered
•Age ≥ 18 years
•WHO performance status 0-2

Exclusion Criteria

•Any other histological component than seminoma
•Additional German specific exclusion criterion - not to be considered for Swiss patients: Patient who is dependent on the sponsor or the investigators according to ICH/GCP E6(R2) guideline
•Additional German specific exclusion criterion - not to be considered for Swiss patients: Patient who has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities according to § 40a (2) AMG
•Elevated levels of Alpha-1-Fetoprotein AFP (≥ 2x ULN)
•Involved nodes (metastatic) in previously irradiated localizations in the abdomen or pelvis
•Any anti-cancer therapy after primary tumor resection in patients presenting with primary stage IIA/B seminoma
•Any serious underlying medical condition (i.e. current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects) or serious co-morbidity which could impair the ability of the patient to participate in the trial (according to investigator's judgment)
•Any treatment in a clinical trial within 28 days prior to registration
•Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or contraindicated for use with radiotherapy
•Known hypersensitivity to trial drugs or to any component of the trial drugs