A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 124
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Surgery may be effective therapy in treating patients with metastatic melanoma.
PURPOSE: This phase II trial is studying how well surgery works in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
- Assess overall and progression-free survival in patients with metastatic melanoma (beyond the draining lymph nodes) after complete surgical resection of all known disease.
- Determine the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with metastatic melanoma who can be resected to a disease-free state.
OUTLINE: This is a multicenter study.
All patients undergo gross total resection of all known disease. Patients whose disease cannot be completely resected or who have disease recurrence after surgery are removed from study. Patients found to have microscopic residual disease after surgery are considered completely resected. Resected tissue is submitted for analysis on protocol SWOG-9431.
Patients may receive any adjuvant therapy (e.g., radiotherapy, interferon, and/or vaccines) deemed clinically appropriate by the treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic melanoma that is deemed grossly surgically resectable
- •Multiple resected sites or metastatic melanoma of unknown primary allowed provided all known disease can be grossly resected
- •Recurrence in iliac lymph nodes after inguinal lymph dissection allowed
- •No metastatic disease beyond the lesions planned for resection
- •Confirmed by CT scan of chest, abdomen, pelvis, and CT or MRI of brain within 42 days of study
- •Concurrent registration on protocol SWOG-9431 required
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which patient is currently disease free
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior immunotherapy in the adjuvant or metastatic setting allowed
- •Chemotherapy:
- •Prior chemotherapy in the adjuvant or metastatic setting allowed
- •Endocrine therapy:
- •Prior hormonal therapy in the adjuvant or metastatic setting allowed
- •Radiotherapy:
- •Prior radiotherapy in the adjuvant or metastatic setting allowed
- •See Disease Characteristics
- •At least 14 days since prior surgery in the adjuvant or metastatic setting
- •Recovered from prior therapy
排除标准
- 未提供
研究组 & 干预措施
surgery
干预措施: Surgery (Procedure)
结局指标
主要结局
Overall survival
时间窗: 1-year
次要结局
未报告次要终点