NL-OMON36748已完成3 期
A phase III, Randomized Trial of Surgical Resection With or Without BCG versus Best Medical Therapy as Initial Treatment in Stage IV Melanoma - MORD-STG4SURG-049
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria
- •All of the following inclusion criteria must be met and certification of eligibility must be
- •obtained from the Principal Investigator in order for the patient to be eligible. A completed,
- •signed and dated consent form is also required prior to randomization and prior to the
- •performance of any protocol-related procedures.;1. Patients must be at least 18 years of age and have a minimum life expectancy
- •(excluding melanoma) of 5 years.
- •2. All known disease must be surgically resectable in the opinion of a participating
- •3. Patients must have a histologic diagnosis of Stage IV melanoma arising from a
- •primary cutaneous site or visceral metastasis from an unknown primary site and
- •be within 4 months of initial stage IV diagnosis.
- •4. Patients may have up to 3 visceral organs involved. Any number of lesions up to
- •6 is allowed.
- •5. Patients must provide informed written consent for participation.
- •6. Patients must have ECOG performance status of 0 or 1.
- •7. Patients must be in good general health with no serious co-morbid illness. Good
- •clinical judgment must be exercised in careful selection of patients who are
- •candidates for surgical resection of distant metastases.
- •8. Laboratory values within 30 days of randomization:
- •a. WBC >3,000/mm3
- •b. Lymphocytes >800/mm3
- •c. Platelets >100,000/mm3
- •d. Creatinine <2.0 mg/dL
- •e. Bilirubin <2.0 mg/dL
- •f. Alkaline phosphatase < 2X upper
- •g. SGOT < 2X ULN
- •h. SGPT < 2X ULN
- •i. LDH < 1.5X ULN
排除标准
- •Exclusion Criteria
- •If any of the following exclusion criteria is met, the patient is ineligible for the study.
- •1. Unresectable metastatic disease or more than 4 months since stage IV
- •2. Brain or bone metastatic sites.
- •3. History of primary uveal or mucosal melanoma.
- •4. Another concomitant diagnosis that limits life expectancy to less than 5 years.
- •5. Chronic immunosuppression due to inherited, acquired or iatrogenic immune
- •defect. This includes active HIV, hepatitis, or use of immunosuppressive
- •medications as a component of anti-rejection therapy for organ transplant, as
- •treatment for an autoimmune disease.
- •6. More than 3 involved visceral organ sites or more than 6 metastatic lesions.
- •7. Psychiatric disorder or organic brain syndrome that might preclude participation
- •in the protocol.
- •8. Diagnosis of other malignancy in the past 5 years except adequately treated low
- •grade malignancies such as basal cell carcinoma, cutaneous squamous cell
- •carcinoma, carcinoma-in-situ of the cervix, or other neoplasm that will not limit life
- •expectancy to less than 5 years.
- •9. Serious cardiac, gastrointestinal, hepatic or pulmonary disease that would make
- •surgical resection high-risk.
- •10. Pregnancy
研究者
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