A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 103
- 试验地点
- 27
- 主要终点
- Event-free Survival
研究概览
简要总结
The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.
详细描述
The standard or usual treatment for this disease includes radiotherapy or radiotherapy combined with chemotherapy or antibody therapy.
These treatments are highly effective at curing most patients with HPV-related cancer of the oropharynx, but short and long-term side effects from treatment can be significant.
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 with pathologically proven diagnosis of HPV-related OPSCC
- •Clinical stage T1-3 N0-1 M0 (UICC/AJCC 8th Ed.)
- •Patients must be eligible for definitive RT or CRT
- •Must be ≥ 18 years of age
- •Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health economics questionnaires in either English or French
- •Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate
- •Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- •In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of patient registration
- •Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
- •The following radiological investigations must be done within 8 weeks of randomization: CT or MR of head and neck (MRI is recommended for base-of-tongue primary tumors); PET-CT scan.
- •Patient must consent to provision of, and investigator(s) must confirm location and commit to obtain a representation of formalin-fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays described in Section 12 (Correlative Studies) may be conducted. Please see the Correlative Manual for details
- •Patient must consent to provision of samples of blood and plasma (for circulating cell free DNA) in order that the specific correlative marker assays described may be conducted.
- •Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
排除标准
- •Previous chemotherapy or radiotherapy treatment for head and neck cancer
- •Patients with an unknown primary.
研究组 & 干预措施
Experimental arm
This is a non-randomized, single-arm study evaluating elective volume-adjusted de-escalation radiotherapy. Patients receive one of two treatment options, based on treating physician discretion. Both options are considered part of a unified treatment strategy and analyzed as a single arm.
- Option 1 (Chemoradiotherapy):
Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 7 weeks (5 fractions/week) Cisplatin: Either 100 mg/m² on days 1, 22, and 43 or 40 mg/m² weekly for 7 weeks
- Option 2 (Radiotherapy Alone):
Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 6 weeks (6 fractions/week)
干预措施: Radiation (Radiation)
Experimental arm
This is a non-randomized, single-arm study evaluating elective volume-adjusted de-escalation radiotherapy. Patients receive one of two treatment options, based on treating physician discretion. Both options are considered part of a unified treatment strategy and analyzed as a single arm.
- Option 1 (Chemoradiotherapy):
Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 7 weeks (5 fractions/week) Cisplatin: Either 100 mg/m² on days 1, 22, and 43 or 40 mg/m² weekly for 7 weeks
- Option 2 (Radiotherapy Alone):
Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 6 weeks (6 fractions/week)
干预措施: Cisplatin (Drug)
结局指标
主要结局
Event-free Survival
时间窗: 2 years
Event free survival (EFS) is defined as the time from the date of registration to the date of first record of any of the following events: * Progression. * Surgery. * Non-protocol RT, chemotherapy, or biologic therapy (for the current cancer diagnosis) without documentation of the site of failure. * Death due to any cause. The outcome is reported as the proportion of patients who remain event-free at 2 years.
次要结局
- Overall Survival(2 years)
- Local-regional Control(2 years)
- Out-of-field Regional Control(2 years)
- Distant Metastasis Free Survival(2 years)