Reduced intensity radio-chemotherapy for stage IIA/B seminoma

Phase 1

Recruiting

• Conditions: Stage IIA/B seminoma; MedDRA version: 21.0Level: PTClassification code: 10043351Term: Testicular seminoma (pure) stage II Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-509663-24-00
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-25
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 180

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 2016. 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, Baseline PRO questionnaires have been completed, Adequate bone marrow function: neutrophil count = 1.0 x 10^9/L, platelet count = 100x 10^9/

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, Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate efficacy of a stage-adapted treatment regimen in stage IIA/B seminoma based on the preliminary experience gained in SAKK 01/10;Secondary Objective: To investigate Response Rate, PFS, TTP, OS Seminoma-specific survival, time to distant metastasis, time to next treatment, localization of progression, method of detection of progression, AE, late AE, incidence of second tumors, development of metabolic syndrome, development of hypogonadism of a stage-adapted treatment regimen in stage IIA/B seminoma.;Primary end point(s): Progression free survival (PFS) at 3 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Response rate (RR);Secondary end point(s):Progression free survival (PFS);Secondary end point(s):Time to progression (TTP);Secondary end point(s):Overall Survival (OS);Secondary end point(s):Seminoma-specific survival;Secondary end point(s):Time to distant metastasis;Secondary end point(s):Time to next treatment;Secondary end point(s):Localization of progression;Secondary end point(s):Method of detection of progression