Pilot Phase II Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Toxicity of treatment based off of Adverse Events collected per CTCAE v5.0
研究概览
简要总结
This study seeks to study the population of HPV-related oropharynx cancer patients that appear to be at highest risk for treatment failure with loco-regional failure and distant metastases including cT4 or cN3. The study team aims to determine if it is feasible to use multi-modality imaging (both DCE MRI and FDG-PET) to optimize the radiation boost in high risk p16+ OPSCC with similar or decreased toxicity compared to historic standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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, locally/regionally advanced p16+ squamous cell carcinoma of the oropharynx referred for definitive chemo-RT
- •AJCC 8 Stage III (cT4 or N3)
- •ECOG 0-1 performance status within two weeks of enrollment
- •Pre-treatment laboratory criteria within four weeks of enrolment: WBC > 3500/ul, granulocyte > 1500/ul. Platelet count > 100,000/ul. Total Bilirubin < 1.5 X ULN. AST and ALT < 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
- •All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
- •Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.
排除标准
- •Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- •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.
- •Patients should have no contraindications to having a contrast enhanced PET 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.
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- •Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if > 3 years prior to study;
研究组 & 干预措施
Treatment Arm
Patients will initially receive a single prescription of 70 Gy to PTVhigh in 35 fractions with RT given once daily, 5 days a week along with weekly platinum (standard therapy). All fields must be treated daily. On days when chemotherapy is given, it will be administered prior to RT. Prescription to high risk PTV will be 70Gy in 35 fractions and to PTV2 will be 56Gy in 35 fractions.
干预措施: Radiation (Radiation)
Treatment Arm
Patients will initially receive a single prescription of 70 Gy to PTVhigh in 35 fractions with RT given once daily, 5 days a week along with weekly platinum (standard therapy). All fields must be treated daily. On days when chemotherapy is given, it will be administered prior to RT. Prescription to high risk PTV will be 70Gy in 35 fractions and to PTV2 will be 56Gy in 35 fractions.
干预措施: Platinum based chemotherapy (Drug)
结局指标
主要结局
Toxicity of treatment based off of Adverse Events collected per CTCAE v5.0
时间窗: up to 3 years from start of treatment
The study team will calculate rates of in-field RT related toxicities including Grade 4+ and Grade 3+ with associated confidence intervals including dysphagia, mucositis, oral pain and oral bleeding events.
次要结局
- Pattern of HPV ctDNA biomarkers in blood(baseline and surveillance, up to 24 months)
- Tumor size of multi-imagine modality directed RT boost(4 weeks after starting treatment)
- Oral microbiome analysis to compile biomarker information(pre and post treatment, up to 24 months)
- Local regional recurrence free survival(up to 3 years from start of treatment)
- Pattern of HPV ctDNA biomarkers in urine(baseline, treatment, and surveillance, up to 24 months)
- Biomarker analysis from tumor tissue, to compile biomarker information(pretreatment and at 2 weeks)
- MRIs and FDG PET scans- efficacy and toxicity(up to 2 years)