NL-OMON43597已完成2 期
Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial - PET Boost
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 160 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients > 18 years with any subtype of pathologically proven, non-small cell lung cancer. The diagnosis may be established from biopsy or cytology obtained from the primary tumor and/ or from metastatic lymph nodes.
- •2. Minimal diameter of the primary tumor 4 cm, to allow boosting of sub-volumes.
- •3. UICC Stage T2-4, N0-3, M0 disease (TNM definition see appendix 2).
- •4. Only stage IB-II patients who are not candidates for surgery are eligible
- •5 Measurable disease at registration.
- •6. ECOG-performance status < 2 (see appendix 6)
- •7. Lung function: FEV1 and DLCO at least 40 % of the age-adjusted normal value
- •8. Willing and able to give a written informed consent.
- •9. Patients with locoregional recurrent lung tumor following surgery or a second primary cancer (at least 3 years after treatment) are eligible, unless a pneumonectomy was performed.
- •10. SUVmax in the pre-treatment FDG-PET scan><= 5 for the primary tumor.
- •11. Adequate organ function, including the following:
- •a. Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) *1.5 x 109/L, platelets * 100 x 109/L, and hemoglobin * 9 g/dL.
- •b. Hepatic: bilirubin * 1.5 times the upper limit of normal (* ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) * 3.0 * ULN.
- •c. Renal: calculated creatinine clearance (CrCl) ><= 45 ml/min based on the original weight based Cockcroft and Gault formula
- •12 For women: Must be surgically sterile, postmenopausal, or compliant with a highly reliable contraceptive method (failure rate <1%) during and for 6 months after the treatment period, must not be breast-feeding.
- •13. For men: Must during chemotherapy take adequate contraceptive measures.
排除标准
- •1. Prior radiotherapy to the thorax.
- •2. Clinical superior vena cava syndrome, malignant pleural effusion or malignant pericardial effusion.
- •3. Tumor growth in large blood vessels on spiral CT scan or encasement >50 %
- •4. Multiple nodules in the same or ipsilateral lobe(s).
- •5. Post-obstructive atelectasis or infiltration that cannot be distinguished from tumor on a CT-PET scan.
- •6. Patients with a diagnosis of other cancer within the last 3-years (except in situ carcinoma*s and / or non-melanoma skin cancer).
- •7. Pregnant or lactating women.
研究者
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