NL-OMON34814已完成3 期
Randomized Phase III trial comparing immediate versus deferred nephrectomy in patients with synchronous metastatic renal cell carcinoma. EORTC 30073 SURTIME - EORTC 30073 SURTIME
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 147 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histologically confirmed metastatic Renal Cell Cancer of clear-cell subtype with a resectable asymptomatic in situ primary.
- •- Metastatic RCC (mRCC): metastases are not completely resectable at the time of
- •surgery or during an additional intervention. Multiple lesions at one site will make
- •the patient not eligible for complete resection.
- •- Histology *clear-cell* subtype: If the diagnosis is not established patients need
- •to undergo a transcutaneous tru-cut needle biopsy of the primary tumor.
- •- Resectable tumor: primary tumor must be resectable and resectability should not
- •be doubtful at entry. Patients with distant metastases and bulky locoregional
- •lymph node metastases larger than the primary tumor can be included if
- •resectability of the lymph nodes is surgically feasible.
- •- Asymptomatic primary: is defined as the absence of symptoms which can be
- •exclusively assigned to the primary tumor such as flank pain and/or gross
- •hematuria necessitating blood transfusion. As para-neoplastic symptoms cannot
- •be assigned to the primary tumor alone in metastatic disease, they are not
- •included in this definition.
- •- Patients who will receive Sunitinib (Sutent®) as background therapy.
- •- Measurable disease according to RECIST 1.1 criteria.
- •- Prior therapies:
- •- Prior systemic therapy for metastatic RCC is not allowed
- •- Prior local radiotherapy for bone lesions is allowed
- •- Concomitant medications:
- •- Investigational or systemic therapy for metastatic RCC must not be used during
- •the period of protocol treatment.
- •- No systemic corticosteroid and/ or other immunosuppressive systemic therapies
- •- Age * 18 years.
- •- Life expectancy > 3 months.
- •- WHO performance status 0 or 1.
- •- Adequate bone marrow function (Leucocytes > 3.0 x 109/l, platelets >100 x 109/l,
- •hemoglobin > 6.0 mmol/l or > 10.0 g/dL.)
- •- Prothrombin time (PT) or international normalized ratio (INR) * 1.2 x upper limit of
- •normal (ULN).
- •- Partial thromboplastin time (PTT) * 1.2 x ULN.
- •- Adequate hepatic function (bilirubin * 1.5 x ULN, SGPT/ALT * 2.5 x ULN or * 5 x
- •ULN if liver lesions).
- •- Serum calcium < 10.0 mg/dL.
- •- Adequate renal function: calculated or measured clearance creatinine >30 ml/min.
- •- Clinically normal cardiac function based on the institutional lower limit of normal
- •LVEF assessed by MUGA or ECHO and normal 12 lead ECG.
- •- Patients with any history of malignancies who are disease-free for more than 5
- •years are eligible.
- •- Women must be post-menopausal with a total cessation of menses of >1 year, or
- •if of childbearing potential must not be pregnant (negative serum pregnancy test
- •at entry) or lactating; and must agree to use effective contraceptive methods
- •(with a documented failure rate < 1% e.g.; vasectomized partner sterile prior to
- •trial entry and sole sexual partner or double-barrier contraception) from 2 weeks
- •before to enrollment. The duration of the contraception will depend on the
- •treatment that patient will receive.
- •- Absence of any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow-up schedule;
- •those conditions should be assessed with the patient before registration in the
- 另有 1 项未显示
排除标准
- •- Patients for whom complete surgical remission can be achieved by
- •removing metastatic sites at nephrectomy or during an additional
- •intervention.
- •- Patients with symptomatic primary necessitating nephrectomy.
- •- Patients with previous partial or total nephrectomy.
- •- Patients with unresectable bulky locoregional lymph node metastases larger than the primary tumor.
- •- Patients with only bone metastases.
- •- Patients having more than 3 of the following surgical risk factors will not be eligible:
- •- serum albumin CTCAE v4.0 grade 2 or worse
- •- serum LDH > 1.5 x UNL
- •- liver metastases
- •- symptoms at presentation due to mestastases
- •- retroperitoneal lymph node involvement
- •- supra-diaphragmatic lymph node involvement
- •- clinical stage T3 or T4
- •- Patients with serious cardiac illness (myocardial infarction and/or (un)treatable angina
- •pectoris not responding to treatment) within the past 12 months.
- •- Uncontrolled high blood pressure (BP) defined as BP * 150/100 mm Hg despite
- •optimal medical therapy.
- •- Clinical signs of CNS involvement.
- •- Current pulmonary disease.
- •- Patients with active or uncontrolled infections or with serious illnesses,
- •malabsorption syndrome or medical conditions, including patients with a history of
- •chronic alcohol abuse, hepatitis, HIV and/or cirrhosis.
- •- History, within the past five years, of malignancies other than renal cell
- •carcinoma (except: basal or squamous cell carcinoma of the skin, in situ carcinoma
- •of the cervix, resected incidental prostate cancer staged pT2 with Gleason Score *
- •6 and postoperative PSA < 0.5 ng/ml).
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