A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 16
研究概览
简要总结
RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to detect the extent of cancer and allow doctors to plan more effective treatment for patients who have testicle cancer.
PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of the testicle.
详细描述
OBJECTIVES:
- Assess the ability of fludeoxyglucose F 18 positron emission tomography to predict relapse requiring adjuvant chemotherapy in patients with high-risk stage I non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis who are on current management protocols.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 1 hour later by positron emission tomography (PET) imaging. Patients with metastatic disease identified by FDG PET imaging may receive adjuvant chemotherapy according to the standard clinical practice at each participating center. Patients with no metastatic disease identified by FDG PET imaging are considered for entry into the MRC-TE08 trial (randomized trial of 2 CT scan frequencies in the surveillance of stage I teratoma) or are followed according to the standard surveillance schedule.
Patients with metastatic disease are followed every 6 months. Patients with no metastatic disease are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 4-6 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Diagnostic
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis with evidence of vascular (lymphatic or venous) invasion in primary specimen
- •Clinical stage I on the basis of clinical examination, chest x-ray, and CT scan of the chest, abdomen, and pelvis
- •Negative post-orchidectomy tumor markers (alpha-fetoprotein and beta human chorionic gonadotropin)
- •High-risk disease
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No evidence of active inflammatory or infective diseases
- •No other disease or prior malignancy that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
- •No more than 8 weeks since prior orchidectomy
- •No prior positron emission tomography scans
排除标准
- 未提供