18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- To correlate 18F-FMISO PET uptake with tumor response at 3 months post radiotherapy, local control rate and disease free survival.
研究概览
简要总结
This study aims to investigate the use of 18F-FMISO PET in identifying hypoxic subvolume for dose escalation radiotherapy in nasopharyngeal cancer and thus improve local control without significant increase in toxicities.
详细描述
The specific aims of this study are:
- To establish hypoxia imaging in NPC patients
- Investigate the dynamics of tumor hypoxia before and during chemoradiation
- Integrate hypoxia imaging into radiation treatment planning protocols
- Design hypoxia adapted radiation schedules
- Identify candidate hypoxia biomarkers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T3-T4 disease with no evidence of distant metastasis.
- •Histological diagnosis of WHO Type II or III NPC
- •No evidence of distant metastases in staging work up (including lung, liver and bone imaging).
- •Planned for upfront radiotherapy and/or chemotherapy.
- •Cross sectional imaging of the primary and neck disease (MRI preferred)
- •Performance status of ECOG grade 0 or 1
- •No prior tumour therapy
- •At least 21 years of age, of either sex.
- •Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential;
- •Adequate bone marrow, renal and hepatic function defined as follows:
- •Bone marrow: WBC > 3000 / mm3 (ANC > 1500 / mm3 ) Platelets > 100 000 / mm
- •Hb > 10 gm/dl Renal: serum creatinine within institutional normal range(or) lower than the lower limit of institutional normal range : calculated creatinine clearance > 50 ml / min Hepatic: enzymes (SAP, SGOT) < 2x normal: bilirubin < 24 mol / l.
排除标准
- •Allergic to 18F-fluoromisonidazole or Nitroimidazoles
- •Planned for neoadjuvant chemotherapy
- •Uncontrolled hypercalcaemia: calcium 2.7 mmol/L (10.8 mg/dL).
- •Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- •Have serious active infection.
- •Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures
结局指标
主要结局
To correlate 18F-FMISO PET uptake with tumor response at 3 months post radiotherapy, local control rate and disease free survival.
时间窗: From baseline up to 5 years
To investigate the dynamics of tumour hypoxia
时间窗: From baseline and during 7 week long treatment regimen
A repeat 18F-FMISO-PET in week 3 of the 7 weeks long treatment regimen is planned. Fractionated radiotherapy is expected to induce reoxygenation within the tumor as iterative process by killing well oxygenated tumor cells with every fraction thereby reducing oxygen demand in the remaining tumor cells. Repetitive hypoxia imaging at week 3 allows for assessment of evolution of hypoxia during radiotherapy.
To evaluate proportion of patients with contour-able hypoxic volume as well as the feasibility of generating dose-escalation radiotherapy plan with dosimetrically achieved parameters for target volume and organs-at-risk.
时间窗: At baseline and week 3 of RT
Number of patients with feasible radiotherapy plan dose-escalation to more than 84Gy
To estimate the correlation between immunohistochemical expression of CA-IX, VEGF and HIF-1a, (marker of hypoxia) and pre-treatment PET-SUV measurement
时间窗: At baseline
次要结局
未报告次要终点