A Phase 2 Study of De-Intensified Risk-Adapted Postoperative Radiation Therapy for Human Papilloma Virus Associated Oropharyngeal Squamous Cell Carcinoma: the ADAPT Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
This research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life.
详细描述
This research study is being done to study if less intensive treatments can be used after surgery for head and neck cancers that are due to the human papilloma virus (HPV). In general, these cancers have better cure rates than other types of head and neck cancers. Therefore, the investigators are studying whether we can safely reduce the amount of treatment after surgery, such as surveillance (instead of using radiation) or less radiation or less chemotherapy, while maintaining good cure rates. The investigators hope that by reducing the intensity of treatment, this will lead to less side effects during and after cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or base of tongue (oropharynx) or unknown primary with p16-positive cervical lymph node metastases
- •HPV-associated tumor as defined by: positive p16 immunohistochemistry (>70%) OR in situ hybridization OR PCR-based methods
- •Eligible for curative-intent surgery with anticipated negative margins
- •Surgery performed at Brigham & Women's Hospital
- •Age 18 or older years.
- •ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A)
- •Normal organ and marrow function as defined below:
- •leukocytes ≥3,000/mcL
- •absolute neutrophil count ≥1,000/mcL
- •platelets ≥100,000/mcL
- •total bilirubin within normal institutional limits
- •AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- •creatinine ≤ 1.5 times the institutional upper limit of normal OR
- •creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- •Patients with ≤20 pack-years of cumulative cigarette smoking. Pack-years are calculated by multiplying the number of years smoked with the pack of cigarettes smoked per day. One pack is considered to contain 20 cigarettes.
- •Tumor clinical stage (AJCC 8th edition): T0 or T1 or T2
- •Nodal clinical stage (AJCC 8th edition): N0 or N1
- •No distant metastases. Clinical M-stage must be M0 (AJCC 8th edition).
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Prior history of head and neck cancer within 5 years.
- •Prior head and neck radiation
- •Clinically fixed or matted nodes
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Note: that HIV positive patients will be eligible.
- •Pregnant women are excluded from this study because of the teratogenic risks of radiation exposure to the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy and supportive care medications required for symptomatic management of head and neck cancer side effects as well as general anesthesia required for oncologic head and neck surgery, breastfeeding should be discontinued if the mother is enrolled in the study. Pregnancy status will be determined by a serum pregnancy test.
研究组 & 干预措施
Low Risk
Observation without adjuvant therapy
- Pathologic T0-2, N0-1
- Minimum of 15 lymph nodes retrieved on neck dissection per dissected side of the neck
- Single positive lymph node up to 3cm
- No extranodal extension
- Clear margins
- Undetectable postoperative circulating tumor HPV DNA
干预措施: Radiation therapy (Radiation)
Intermediate Risk
Reduced-dose radiation (46Gy)
- Pathologic T0-2N0-2 and any one of the following features:
- 2 or more positive lymph nodes
- single node >3cm
- <15 lymph nodes retrieved on neck dissection for each side of the neck
- Positive lymph nodes in level IB, IV, or V
-≤1mm extranodal extension
- Positive lymph node(s) contralateral to the primary tumor
- Close margins
- Detectable postoperative circulating tumor HPV DNA
干预措施: Radiation therapy (Radiation)
High Risk
Postoperative radiation (60Gy) without chemotherapy
- Pathologic T0-4N0-2 and any one of the following features:
->1mm extranodal extension
- Microscopic positive margins
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Disease-free survival
时间窗: 2 years
Survival without any signs or symptoms of cancer after the treatment ends.
次要结局
- Overall Survival(2 years)
- Toxicity Rate(2 years)
- Quality Of Life Questionnaire(2 Years)
- Symptom burden:(2 years)
- Dysphagia(2 Years)
- Shoulder dysfunction(2 Years)
研究者
Danielle Margalit, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute