A randomized double blind phase III study to evaluate adjuvant cG250 treatment versus placebo in patients with clear cell RCC and high risk of recurrence

Wilex AG0 个研究点目标入组 612 人开始时间: 2004年10月5日最近更新: 2012年5月1日

适应症

试验速览

暂无简介。

•1.Prior nephrectomy of primary renal cell carcinoma with documented clear cell histology
•2.Adenectomy of regional lymph nodes and staging is required
•3.No evidence of macroscopic and microscopic residual disease
•4.Patients should have one of the following (referring to TNM classification, 6th edition UICC, 2002):
•- histologically proven stage T3bN0M0 or T3cN0M0 or T4N0M0
•- any histologically proven T stage and N+ disease or
•- primary tumor T1bN0M0 or T2N0M0 or T3aN0M0 and microscopic vascular invasion and grade > or = III (Fuhrman or any other nuclear grading system with at least 3 grades)
•5.ECOG of 0
•6.Randomisation needs to be performed within 6 weeks after nephrectomy
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1Pre-exposure to murine/chimeric antibody therapy
•2.Patients who require or are likely to require corticosteroids for another disease (patients on physiologic corticosteroid replacement therapy may be included in the study at the discretion of the investigator)
•3.Patients with prior organ transplantation
•4.Laboratory values obtained <= 14 days prior to registration:
• -White blood cells (WBC) <= 3.0 x 108/dl
• -Platelet count <= 100 x 108/dl
• -Hemoglobin <= 6.2 mmol/l (equals 10 g/dl)
• -Total bilirubin >= 1.5 x upper limit of normal (ULN)
• -ASAT, ALAT >= 3 x ULN
• -Serum creatinine >= 2 x ULN
•5.Patients with a history of prior malignancies within the last 5 years, except for surgically-cured non-melanoma skin cancer, or cervical carcinoma in situ
•6.Patients who received prior radiation or chemotherapy within the last 5 years

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