ACTRN12607000063415已完成3 期
Trans Tasman Radiation Oncology Group (TROG) 02.01 - A randomised clinical trial of surgery versus surgery plus adjuvant radiotherapy in patients with completely resected macroscopic nodal metastatic melanoma to improve regional relapse rates.
Bryan Burmeister0 个研究点目标入组 250 人开始时间: 2003年12月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •All of the following criteria must apply for the patient to be eligible for the trial:
- •1. Regional macroscopic (palpable) nodal metastatic melanoma in one nodal basin region only (either parotid/neck, axilla or groin) which has been completely resected.
- •Patients presenting according to any of the three following ways are eligible: node metastases (i) occurring concurrently with the initial diagnosis of primary melanoma, (ii) appearing subsequently after the successful treatment of the primary, or (iii) as a first presentation of melanoma with an unknown primary.
- •Patients who undergo two or more operations to achieve total standards specified for lymphadenectomy must complete them within 8 weeks. A previous biopsy (open or closed) where the operative intent was not a definitive curative procedure does not need to be included within this 8 week period. Patients who undergo a procedure that is not curative in intent (e.g. revision of wound edges) after a definitive procedure that is curative in intent (e.g. inguinal
- •lymphadenectomy) will need to have this procedure completed within 12 weeks following the final definitive procedure.
- •2. A completed Synoptic Pathology Report which states that:
- •(a) resection is complete
- •(b) the lymphadenectomy specimen contains the required minimum numbers of
- •harvested nodes in the involved sites, as follows:
- •Superficial parotidectomy 2
- •Neck dissection
- •Comprehensive (levels I-V) 25
- •4 levels (e.g. Sentinal Node Dissection (SND) (I-IV) or Sentinal Node Dissection (SND) (II-V, +/-postauricular/occipital) 20
- •3 levels (e.g. Sentinal Node Dissection (SND) (I-III) or Sentinal Node Dissection (SND) (III-V)
- •Axillary dissection 10
- •Superficial inguinal dissection (4 for deep inguinal/pelvic node dissection if
- •performed in conjunction with superficial inguinal dissection) 6
- •3. At significant risk of regional relapse, defined as at least one of the following being present (as per Synoptic Pathology Report):
- •a) the number of nodes involved is:
- •> 1 node for parotid, or
- •> 2 nodes for neck or axilla, or
- •> 3 nodes for groin.
- •or b) Extranodal tissue spread;
- •or c) Any one metastatic node of maximum diameter = 3 cm neck, or = 4 cm in axilla or groin.
- •4. All staging investigations have been completed: Computed Tomography (CT) of nodal basin, Computed Tomography of
- •chest/abdomen/pelvis and Computed Tomography of brain. (Brain Magnetic Resonance Imaging may be substituted for brain Computed Tomography for initial staging only.)
- •5. Serum Lactate Dehydrogenase (LDH) < 1.5 times the upper limit of normal.
- •6. World Health Organisation (WHO) performance status of 0 or 1.
- •7. Age 18 years or older.
- •8. Expected life span of two or more years in the absence of melanoma.
- •9. A photograph has been taken of the involved nodal basin region; the photograph is to include the recent lymphadenectomy scar(s) and the defined anatomic boundaries drawn on the skin
- •for the node basin region concerned (refer to section 8.2 for details).
- •10. Radiotherapy must be able to be commenced within 12 weeks of lymphadenectomy.
- •11. Patient must not be pregnant and if fertile must use a medically acceptable contraceptive throughout the treatment period.
- •12. Written informed consent has been given.
排除标准
- •None of the following criteria must apply for the patient to be eligible for the trial.
- •1. Evidence of active or previous local recurrence or in transit disease; or evidence of nodal metastases or regional disease beyond the lymphadenectomy bed.
- •2. Evidence of distant metastases on clinical or radiological investigation.
- •3. Patients with prior cancers, except: those diagnosed more than five years ago with no evidence of disease recurrence within this time and with clinical expectation of recurrence of less than 10 %; and successfully treated basal cell or squamous cell skin carcinoma; and carcinoma in situ of cervix; and multiple primary melanoma. However, any patient with previous invasive breast cancer or prostate cancer is excluded.
- •Note: Treatment with adjuvant systemic therapy does not exclude participation in the trial. However cytotoxic drugs, other than interferon, should not be delivered during, or in close association with, radiation treatment. Documentation of adjuvant systemic therapy will be required.
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