Carboplatin chemotherapy and involved node radiotherapy in stage IIA/B seminoma. - SAKK01/10

SAKKSchweizerische Arbeitsgemeinschaft für Klinische Krebsforschung0 个研究点目标入组 120 人开始时间: 2013年10月14日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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).

发起方

SAKKSchweizerische Arbeitsgemeinschaft für Klinische Krebsforschung