Stopped: Board decided to prematurely terminate the follow-up phase of the trial due to funding reasons
Germany120 participantsStarted 2012-06-15
Plain-language summary
The main objective of this trial is to test the efficacy and safety of carboplatin chemotherapy and involved node radiotherapy in patients with stage IIA/B seminoma.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 is pT1-4 cN1-2 cM0 according to UICC TNM 2009.
* Multi-slice CT or MRI or FDG-PET-CT of the chest, abdomen and pelvis or a FDG-PET-CT within 4 weeks prior to patient registration, showing stage IIA/B disease. I.v. contrast medium has to be administered.
* Age ≥ 18 years.
* WHO performance status 0-2.
* 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).
* Patient agrees not to father a child during trial treatment and during 12 months thereafter.
* Patient has been proposed sperm conservation.
* Patient compliance and geographic proximity allow proper staging and follow-up for at least 3 years.
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…