低危 HPV 相关口咽鳞状细胞癌患者的降阶梯放疗 (EVADER)
低危 HPV 相关口咽鳞状细胞癌患者选择性容积调整降阶梯放射治疗 (EVADER) 的 II 期单臂试验
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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British Columbia
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Prince George、British Columbia、加拿大、V2M 7E9
- BCCA - Centre for the North
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Vancouver、British Columbia、加拿大、V5Z 4E6
- BCCA - Vancouver Cancer Centre
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Manitoba
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Winnipeg、Manitoba、加拿大、R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's、Newfoundland and Labrador、加拿大、A1B 3V6
- Dr. H. Bliss Murphy Cancer Centre
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Ontario
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Hamilton、Ontario、加拿大、L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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Kingston、Ontario、加拿大、K7L 2V7
- Kingston Health Sciences Centre
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Ottawa、Ontario、加拿大、K1H 8L6
- Ottawa Hospital Research Institute
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Toronto、Ontario、加拿大、M5G 2M9
- University Health Network
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Toronto、Ontario、加拿大、M4N 3M5
- Odette Cancer Centre
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Quebec
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Montreal、Quebec、加拿大、H4A 3J1
- The Research Institute of the McGill University
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Montreal、Quebec、加拿大、H3T 1E2
- The Jewish General Hospital
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Québec、Quebec、加拿大、G1R 2J6
- Hotel-Dieu de Quebec
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Sherbrooke、Quebec、加拿大、J1H 5N4
- CIUSSS de l'Estrie - Centre hospitalier
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Saskatchewan
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Regina、Saskatchewan、加拿大、S4T 7T1
- Allan Blair Cancer Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous chemotherapy or radiotherapy treatment for head and neck cancer
- Patients with an unknown primary.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：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.
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
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) |
35 fractions, 5/wk, 7 wks 70Gy/56Gy, or 35 fractions, 6/wk, 6 wks, 70Gy/56Gy, or 35 fractions, 5/wk, 7 wks OR 6/wk, 6 wks 70Gy/56Gy
其他名称：
100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Event-free Survival
大体时间：2 years
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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:
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Survival
大体时间：2 years
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For patients who have died, overall survival is calculated in months from the day of registration to date of death. Otherwise, overall survival is censored at the last day the patient is known alive (LKA). The outcome is reported as the proportion of patients who remain alive at 2 years. |
2 years
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Local-regional Control
大体时间：2 years
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Local-regional control is defined as the time from the date of registration to the date of any of the following, whichever comes first:
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2 years
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Out-of-field Regional Control
大体时间：2 years
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Time to out-of-field regional failure is defined as the time from the date of registration to the date of the first record of appearance of regional progression/recurrence outside the treatment field , or to the date of neck dissection at any time after registration with tumour present/unknown performed for clinical or radiological disease progression outside the target volumes whichever comes first. The outcome is reported as the proportion of patients who remain out-of-field regional control free at 2 years. |
2 years
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Distant Metastasis Free Survival
大体时间：2 years
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Distant metastasis free survival is defined as the time from the date of registration to the date of first record of appearance of distant metastasis or death for any cause. Local-regional failure or second cancers diagnosed before the distant metastases are not considered events of interest for this endpoint. Subjects alive and free of distant metastasis are censored at the date of the most recent follow-up examination. The outcome is reported as the proportion of patients who remain distant metastasis event-free at 2 years. |
2 years
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合作者和调查者
调查人员
- 学习椅：Scott Bratman、Princess Margaret Cancer Centre, Toronto, ON
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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