Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Disease Free Survival (DSF) time
研究概览
简要总结
This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have pathologically-confirmed, non-metastatic locally/regionally advanced squamous cell carcinoma of the head and neck, stage III/IV, referred for definitive chemo-RT, and meet one of the following six criteria:
- •Primary tumor (T4) with or without metastatic lymph nodes. Tumor or nodes are: unresectable, resection is considered by the treating surgeon or patient to result in unacceptable functional or oncological results, patient refuses surgery, or surgery is not possible due to comorbidities.
- •HPV(-) (Human Papillomavirus) or p16(-) locally/regionally advanced (T3-4 or N2-3) oropharyngeal cancer.
- •HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer.
- •T3 or T4 laryngeal or hypopharyngeal cancer that is locally advanced, bulky (>40 cc*), unresectable, or patient declines surgery.
- •Stage III/IV oral cavity or paranasal sinus cancers in patients who refuse surgery or are unfit for surgery.
- •Locally/regionally advanced (stage T3-4 and/or N3) nasopharyngeal cancer which is EBV (-) (Epstein-Barr Virus).
- •KPS (Karnofsky Performance Status: A measure of general well being and activities of daily living; scores range from 0 to 100 where 100 represents perfect health) >70 (see Appendix A) within two weeks of enrollment.
- •Pre-treatment laboratory criteria within four weeks of enrollment:
- •WBC (White Blood Cell) > 3500/ul, granulocyte > 1500/ul.
- •Platelet count > 100,000/ul.
- •Total Bilirubin < 1.5 X ULN.
- •AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) < 2.5 X ULN.
- •Estimated Creatinine clearance >30cc/min.
- •Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist.
- •Patients are adults (Age ≥18).
- •All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
排除标准
- •EBV (+) Nasopharyngeal Carcinoma in the protocol treated tumor.
- •Prior head and neck radiation.
- •Documented evidence of distant metastases.
- •Patients with active infection.
- •Pregnant women.
- •Patients should have no contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
研究组 & 干预措施
Control Arm
Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
干预措施: Cisplatin (Drug)
Control Arm
Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
干预措施: Carboplatin (Drug)
Control Arm
Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
干预措施: IMRT (Intensity-Modulated Radiation Therapy) (Radiation)
Boost Arm
Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
干预措施: Cisplatin (Drug)
Boost Arm
Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
干预措施: Carboplatin (Drug)
Boost Arm
Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
干预措施: IMRT (Intensity-Modulated Radiation Therapy) (Radiation)
Boost Arm
Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
干预措施: Boost Radiation to Hypoperfused Volumes (Radiation)
结局指标
主要结局
Disease Free Survival (DSF) time
时间窗: 3 years post treatment
Kaplan-Meier curves with point-wise 90% confidence intervals will be generated for each treatment arm, overall and by strata. Estimates with confidence intervals will be generated from these curves for the usual summary statistics, including median DFS times and DFS at 1, 2, and 3 years.
次要结局
- Number of patients with adverse events(3 years post treatment)
- Proportion of patients in which hypoperfused/low-diffusion subvolumes overlap with recurrence volumes(3 years post treatment)
- Local-regional control rate(3 years post-treatment)
- Correlation coefficient between continuous dose and perfusion summary measures(2 weeks post Radiation Therapy (RT))