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

Canadian Cancer Trials Group27 个研究点分布在 1 个国家目标入组 103 人2019年6月28日

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.

注册库

clinicaltrials.gov

开始日期

2019年6月28日

结束日期

2026年12月31日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Canadian Cancer Trials Group

责任方

Sponsor

入排标准

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

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

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

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.