NL-OMON47131已完成3 期
Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group - EORTC protocol 18071
Bristol-Myers Squibb0 个研究点目标入组 60 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
- 60
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
- •ELIGIBILITY CRITERIA
- •To be eligbile to participate in this study, patients must be/ have
- •* At least 18 years of age
- •* No mucosal or ocular (eye) melanoma, or melanoma with unknown origin of the
- •* Complete surgical removal (resection) of Stage III melanoma with cutaneous melanoma spread to lymph node,confirmed by microscopy and classified by the American Joint Committee on Cancer (AJCC, 2002) as: Stage IIIA with metastasis greater than 1mm thick; any Stage IIIB or IIIC (no in*transit spread)
- •* Adequate removal of Stage III lymph nodes per Criteria for adequate surgical procedures for complete lymph node dissection (CLND) as documented on the operating report and pathology report. (Patients without documentation of
- •adequate resection are not eligible).
- •* General recommendations for surgical and pathological procedures are given in Appendix J of the protocol; a data quality check will be done based on the surgical and pathological reports
- •* Recommendations for management of the lymph nodes are given in Appendix
- •J of the protocol and should include the following:
- •Head and Neck
- •* Minimum of 15 pathologically investigated nodes
- •* Face, ear and anterior scalp: parotidectomy plus modified radical neck dissection
- •* Posterior scalp: modified radical neck dissection plus suboccipital
- •Upper Extremity
- •* Minimum of 10 pathologically investigated nodes
- •* Axillary node dissection included at least 10 nodes taken from Levels I and II
- •* Level III nodes dissected if they were clinically involved
- •* Pectoralis minor muscle was divided or sacrificed
- •Lower Extremity
- •* Minimum of 5 pathologically investigated nodes
- •* Superficial inguinal node dissection was performed for non*palpable nodal involvement
- •* If Cloquet*s node was positive, a deep inguinal node dissection was
- •performed Lymph Node Dissection for Nodal Recurrence
- •* Regional node recurrence was treated using the appropriate lymphadenectomy as above
- •* Diagnosis of regional node recurrence was made by fine needle aspiration technique to avoid contaminating the region with tumour, followed by Cloquet's Lymph Node Dissection as above
- •* Full lymphadenectomy must be performed within 12 weeks (84 days) prior to
- •randomisation
- •* Disease status for the post*surgery baseline assessment must be documented by full Chest/ Abdomen/ Pelvis CT and/or MRI with Neck CT and/or MRI (for
- •Head and Neck primary tumours) and complete clinical examination after the
- •informed consent and prior to randomisation
- •* The complete set of baseline radiographical images must be available before
- •randomisation and all images must be of adequate quality
- •* Disease*free (no loco*regional relapse or distant metastasis); no clinical
- •evidence for brain metastases
- •* No radiation therapy to the lymph node dissection field after surgery
- •* No prior therapy for melanoma except surgery for primary melanoma lesions;
- •patients who have previously received interferon (IFN) are not eligible
- •* No prior or concomitant therapy with any anti*cancer agents, immunosuppressive agents; other investigational anti*cancer therapies, or chronic use of systemic corticosteroids (used in the management of cancer or non*cancer*related illnesses)
- •* No non*cancer vaccine therapy can be used for prevention of infectious diseases (up*to) 4 weeks prior and after any dose of ipilimumab or placebo <br
排除标准
- •This is mentioned in the Eligibility criteria
研究者
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