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.
Radiation: Involved node RT
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Locations near you
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Full eligibility criteria for NCT01593241
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
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 (active surveillance for stage I disease is not considered as a treatment).
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).
All locations for NCT01593241
Aachen, Germany, 52074
Berlin Universitätsklinik Charité
Berlin, Germany, 10117
Berlin Vivantes - Urban
Berlin, Germany, 10967
Berlin Vivantes - Neukölln
Berlin, Germany, 12351
Düsseldorf, Germany, D-40225
Essen, Germany, 45136
Hamburg Universitätsklinikum - Eppendorf
Hamburg, Germany, 20246
Krefeld Maria-Hilf Krankenhaus
Krefeld, Germany, 47805
Köln, Germany, 50937
München, Germany, 81545
Tübingen, Germany, 72076
Ulm, Germany, 89075
Aarau, Switzerland, CH-5001
Baden, Switzerland, 5404
Basel, Switzerland, 4031
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, Switzerland, CH-6500
Bern, Switzerland, 3010
Biel, Switzerland, CH-2501
Chur, Switzerland, 7000
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland, CH-1011
Olten, Switzerland, CH-4600
Hopital de Sion
Sion, Switzerland, 1951
Kantonsspital - St. Gallen
St. Gallen, Switzerland, 9007
Thun, Switzerland, 3600
Winterthur, Switzerland, 8401
View full eligibility
Tris trial is registered with FDA with number: NCT01593241. The sponsor of the trial is Swiss Group for Clinical Cancer Research and it is looking for 115 volunteers for the current phase.
Official trial title: Carboplatin Chemotherapy and Involved Node Radiotherapy in Stage IIA/B Seminoma
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