NL-OMON43637已完成3 期
Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial (EAGLE FM) - Evaluation of Groin Lymphadenectomy Extent For Metastatic Melanoma EAGLE FM
Australia and New Zealand Melanoma Trials Group0 个研究点目标入组 30 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
- 30
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
- 12 至 99（—）
入选标准
- •Patients may be included in the study if they meet ALL of the following criteria:
- •1. Must be 15 and above.
- •2. Have primary cutaneous melanoma or if the patient presents with stage III melanoma with no known primary tumour then a thorough search for the primary should be documented (including perineal and perianal areas).
- •3. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
- •4. Must have one or multiple inguinal node(s) involved, histologically or cytologically proven as metastatic melanoma. This can can be detected:
- •* At the time of diagnosis;
- •* Or by Ultrasound detection;
- •* Or later after relapse when no Sentinel Node Biopsy (SNB) was performed at the time of primary tumour management;
- •* Or as a result of SNB;
- •* Or at the time of regional recurrence after *false negative* SNB;
- •5. Absent distant disease clinically and on PET/CT scan. (Patients must have NO further distant disease or visceral metastases).
- •6. ECOG performance status must be between 0 to 2 at randomisation.
- •7. Whole body PET/CT scan, specifically stating there is NO evidence of pelvic lymph node involvement prior to randomisation and CT Brain or MRI Brain. Scans must be performed within 4 weeks of randomisation.
- •8. Able to provide written, informed consent.
- •9. Willing to return to the centre for follow up examinations and procedures, as outlined in the protocol.
- •10. All patients must be randomised and undergo lymphadenectomy surgery no more than 90 days following diagnosis of inguinal LN involvement.
排除标准
- •Patients will be excluded from the study for ANY of the following reasons:
- •1. Distant metastatic disease on clinical examination or staging imaging (whole body PET/CT scan and CT or MRI brain scan). Scans must be performed within 4 weeks of randomisation.
- •2. Pelvic LN involvement on SNB or PET/CT scan suggestive of metastatic disease in the pelvis - criteria for diagnosis include normal size or enlarged lymph nodes (> 1 cm) with increased FDG activity on PET (SUV >3). If there are enlarged, necrotic lymph nodes FDG activity on PET is not required to be present. If unsure central review facilitated by the Trial Coordinating Centre should be sought.
- •3. Bilateral inguinal lymph node involvement.
- •4. Patients with a history of major pelvic surgery and / or regional radiotherapy at any time in the past.
- •5. Requiring planned radiotherapy following surgery due to macroscopic, bulky and matted nodes.
- •6. Unfit for General Anaesthesia.
- •7. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
- •8. Patients with prior cancers, except:
- •* those with a thin <=1 mm, regionally unrelated melanoma > 5 years ago.
- •* those with a good prognosis regionally unrelated cancer (>90% probability of 10 years disease specific survival).
- •* other cancers diagnosed more than five years ago with no evidence of disease recurrence within this time.
- •* successfully treated basal cell and squamous cell skin carcinoma.
- •* carcinoma in-situ of the cervix.
- •9. A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol.
- •10. Positive urine pregnancy test for women of childbearing potential (+/-7 days of randomisation onto the trial).
- •The patient treatment history (including adjuvant systemic therapy clinical trial participation) will be recorded at the first study visit and as appropriate throughout the duration of the study. Patients can receive treatment using neoadjuvant therapies prior to and during this trial.
研究者
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