ACTRN12614000721606进行中（未招募）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 to evaluate survival, morbidity, and quality of life ( 01.12 EAGLE FM Trial)
Melanoma and Skin Cancer Trial0 个研究点目标入组 101 人开始时间: 2014年7月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 101
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 15 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients may be included in the study only 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:
- •a. At the time of diagnosis;
- •b. Or by Ultrasound detection;
- •c. Or later after relapse when no Sentinel Node Biopsy (SNB) was performed at the time of primary tumour management;
- •d. Or as a result of SNB;
- •e. Or at the time of regional recurrence after false negative” SNB;
- •f. 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 a CT Brain or MRI Brain scan. Scans must be performed within 6 weeks prior to 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 120 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 (CT/MRI brain or whole body PET/CT scan). Scans must be performed within 6 weeks prior to 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 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:
- •a. those with a thin <=1 mm, regionally unrelated melanoma > 5 years ago
- •b. Those with a good prognosis regionally unrelated cancer (>90% probability of 10 years disease specific survival)
- •c. Other cancers diagnosed more than five years ago with no evidence of disease recurrence within this time
- •d. Successfully treated basal cell and squamous cell skin carcinoma
- •e. Carcinoma in-situ of the cervix
- •f. 1 episode of in transit melanoma > 3 years ago
- •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)
研究者
相似试验
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)metastases of melanoma in the lymph nodes of the groin100416411002747610040795NL-OMON43637Australia and New Zealand Melanoma Trials Group30
招募中
不适用
Pelvic and Para-aortic Lymphadenectomy in Patients with Stage I or II Endometrial Cancer with High Risk of Recurrence (ECLAT; AGO-OP.6) A Multicenter, Prospective Randomized Controlled TrialKCT0004981niversity Medical Center Gottingen10
招募中
不适用
Endometrial Cancer Lymphadenectomy Trialendometrial cancerJPRN-jRCT1030210303Yabuno Akira15
招募中
1 期
Subtotal integumentectomy for treatment of malignant melanoma with indocyanine green(ICG)malignant melanomaJPRN-UMIN000035972Faculty of Life Sciences, Kumamoto University10
招募中
1 期
Role of lymph node removal in patients undergoing in surgery for Carcinoma Ovary after chemotherapy.CTRI/2017/10/010031IRB CMCH Vellore120