Carboplatin chemotherapy and involved node radiotherapy in stage IIA/B seminoma.
- Conditions
- Seminoma stage IIa/b
- Registration Number
- DRKS00005026
- Lead Sponsor
- SAKKSchweizerische Arbeitsgemeinschaft für Klinische Krebsforschung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 120
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
- 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).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) at 3 years
- Secondary Outcome Measures
Name Time Method - Adverse events (AEs) temporarily associated <br>with the trial treatment (within 30 days after treatment)<br><br>- Late AEs (within 20 years after treatment)<br><br>- Incidence of secondary malignancies<br><br>- Response rate<br><br>- Time to progression (TTP)<br><br>- Overall survival (OS) (in between 20 years)<br><br>- Seminoma specific survival (in between 20 years)<br><br>- PFS (in between 3 years)<br><br>- Localization of progression<br><br>- Development of metabolic syndrome<br><br>- Development of hypogonadism