Seminoma stage IIa/b
Conditions
Interventions
Group 1: Day 1: 1 dose (21 days) Carboplatin 10mg/ml Accord AUC7
from Day 22: radiotherapy 30Gy (stage IIa) or 36 Gy (stage IIb).
The total duration of treatment is 6 weeks for patients with stage IIA
Sponsors
SAKK
Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patient has given written informed consent before registration. - Histologically confirmed classical seminoma treated with primary inguinal orchidectomy - Tumor stage at diagnosis or at relapse after primary active surveillance is pT1-4 cN1-2 cM0 according to UICC TNM 2009 (see Appendix 2) [15]. - Multi-slice CT of the chest, abdomen and pelvis or a FDG-PET -CT within 4 weeks prior to patient registration, showing stage IIA/B disease (see Appendix 3). Oral and i.v. contrast have to be administered. - Age = 18 years. - WHO performance status 0-2 (see Appendix 5). - Adequate hematological values: neutrophils = 1.0 x 109/L, platelets = 100x 109/L. - Adequate renal function (calculated creatinine clearance = 50 ml/min, according to the formula of Cockcroft-Gault, see Appendix 4). - Patient agrees not to father a child during trial treatment and during 12 months thereafter. - Patient has been proposed sperm conservation. - Patient compliance
Exclusion criteria
Exclusion criteria: - Previous or concurrent malignancy within 5 years with the exception of localized non-melanoma skin cancer or stage I seminoma for patients entering the trial with relapse during active surveillance. - Psychiatric disorder precluding understanding of information on trial-related topics or giving informed consent or interfering with compliance for treatment schedule. - Mixed histology seminoma. - Elevated levels of AFP (=ULN) at any time. - Any prior abdominal/pelvic radiotherapy (RT). - Any anti-cancer therapy after primary tumor resection. - Any treatment in a clinical trial within 30 days of trial entry. - Any serious underlying medical condition or serious co-morbidity (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial. - Any contraindication for the trial drug (for example, known hypersensitivity to trial drug or to any other co-component of the trial drug, past or current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects). - Any concomitant drugs contraindicated for use with the trial drug according to the approved product information (for example, nephrotoxic or ototoxic medicines).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| - Adverse events (AEs) temporarily associated with the trial treatment (within 30 days after treatment) - Late AEs (within 20 years after treatment) - Incidence of secondary malignancies - Response rate - Time to progression (TTP) - Overall survival (OS) (in between 20 years) - Seminoma specific survival (in between 20 years) - PFS (in between 3 years) - Localization of progression - Development of metabolic syndrome - Development of hypogonadism | — |
Countries
Germany, Switzerland
Contacts
Public ContactJens Bedke
Universitätsklinikum Tübingen Klinik für Urologie
Outcome results
None listed