CARBOPLATIN for Testicular seminoma (Stage IIA/B)

Inclusion criteria

• {"criterion_text":"- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures\n- Adequate renal function: creatinine clearance ≥ 60 ml/min calculated according to the CKD-EPI formula\n- 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\n- Histologically confirmed classical seminoma treated with primary inguinal orchidectomy or partial orchidectomy\n- 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\n- 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.\n- 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\n- Age ≥ 18 years\n- WHO performance status 0-2\n- Baseline PRO questionnaires have been completed\n- Adequate bone marrow function: neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 100x 10^9/L"}

Exclusion criteria

• {"criterion_text":"- Any other histological component than seminoma\n- 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\n- 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\n- Elevated levels of Alpha-1-Fetoprotein AFP (≥ 2x ULN)\n- Involved nodes (metastatic) in previously irradiated localizations in the abdomen or pelvis\n- Any anti-cancer therapy after primary tumor resection in patients presenting with primary stage IIA/B seminoma\n- 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)\n- Any treatment in a clinical trial within 28 days prior to registration\n- Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or contraindicated for use with radiotherapy\n- Known hypersensitivity to trial drugs or to any component of the trial drugs\n- 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"}

Primary endpoints

• {"endpoint_text":"- Progression free survival (PFS) at 3 years","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Response rate (RR)\n- Progression free survival (PFS)\n- Time to progression (TTP)\n- Overall Survival (OS)\n- Seminoma-specific survival\n- Time to distant metastasis\n- Time to next treatment\n- Localization of progression\n- Method of detection of progression","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

29-07-2024

Latest Decision Or Authorization Date

12-08-2024

Processing Time Days

14

Number Of Sites

9

Number Of Participants

95

Switzerland

Number Of Participants

85

Primary sponsor

Full Name

Swiss Group for Clinical Cancer Research

Organisation Type

Patient organisation/association

Country Of Registered Address

Switzerland

Contract research organisations

Name

CROLLL GmbH Auftragsforschungsinstitut (CRO)

Responsibilities

1,12

Third parties

• {"country":"Germany","full_name":"CROLLL GmbH Auftragsforschungsinstitut (CRO)","duties_or_roles":"1,12","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"University Of Basel","duties_or_roles":"4","organisation_type":"Educational Institution"}