Carboplatin chemotherapy and involved node radiotherapy in stageIIA/B seminoma

Swiss Group for Clinical Cancer Research SAKK0 个研究点目标入组 120 人开始时间: 2013年7月8日最近更新: 2020年7月13日

适应症

试验速览

暂无简介。

•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.
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•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 surveilance.
•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).

发起方

Swiss Group for Clinical Cancer Research SAKK