ACTRN12607000164493进行中（未招募）2 期
Trans Tasman Radiation Oncology Group (TROG) 05.02 - A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-Gastric Marginal Zone Lymphoma to improve response rates.
Trans Tasman Radiation Oncology Group (TROG)0 个研究点目标入组 100 人开始时间: 2007年3月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •1. Patients of at least 18 years of age with histologically documented non-gastric marginal zone lymphoma. 2. Disease limited to stages I and II after adequate staging, patients with stage IV with extranodal disease confined to paired organs (e.g. salivary glands) and including any local extension of this disease into adjacent tissues. Patients with involved lymph nodes on the same side of the diaphragm in addition to paired organ involvement are also eligible, provided all involved tumour sites, nodal and extranodal, can be irradiated to 30Gy within tolerance of the relevent normal tissues. If paired organ involvement was regarded as a single extranodal site (rather than 2 seperate sites and hencs stage IV), eligible patients would then be regarded as having stage IE or IIE disease. Patients with wider dissemination (bone Marrow, liver etc) are ineligible. 3. Anticipated life expectancy > 2 years 4. Given written informed consent 5. Been assessed by a radiation oncologist 6. Agree to undergo breath testing for H. pylori and/or oesophagogastroduodenoscopy to exclude active infection with helicobacter pylori 7. Must be available for long-term follow up.
排除标准
- •1. Splenic marginal zone lymphoma 2. Received previous locoregional radiotherapy 3. A medical contraindication to radiotherapy 4. Any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years. 5. Such extensive involvement of the thorax that treatment with radiotherapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed 6. Suspected or confirmed pregnancy. 7. Transformation to large cell lymphoma or other aggressive histology. 8. Disease that is widely disseminated (bone marrow, liver etc)
研究者
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