De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 508
- 试验地点
- 1
- 主要终点
- Phase II: 1-year PEG feeding tube dependence rate
研究概览
简要总结
This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.
详细描述
This study aims to determine whether it is possible to achieve an individual target volume concept that eliminates elective irradiation of uninvolved lymph drainage areas while maintaining clearly defined surgical standards and using modern imaging and radiation techniques. The aim of this study is to achieve reduced late toxicity without compromising locoregional control.
Patients will be randomized to: either RT to primary tumor region, regions with lymph node metastases and elective nodal irradiation (control arm) or RT to primary tumor region and regions with lymph node metastases without elective nodal irradiation (investigational arm)
A two-stage design was chosen for this purpose.
Phase II:
A randomized phase II study whose primary endpoint is the 1-year percutaneous endoscopic gastrostomy (PEG) tube dependence rate will be performed first.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0))
- •Surgery of primary tumor and neck dissection performed according to predefined surgical standard
- •Indication for postoperative radio(chemo)therapy
- •No lymph node metastases > 6cm
- •Lymph node metastases in not more than 3 lymph node level
- •No distant metastases (cM0)
- •Age ≥ 18 years, no upper age limit
- •Eastern Cooperative Oncology Group (ECOG) ≤ 2
- •Patients who understood protocol contents and are able to behave according to protocol
- •Signed study-specific consent form prior to therapy
- •Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications)
排除标准
- •macroscopic incomplete resection R2
- •Distant metastases (cM1)
- •Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)
- •Lymph node metastases in > 3 lymph node level
- •pregnant or lactating/nursing women
- •fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment
- •Any condition potentially hampering compliance with the study protocol and follow-up schedule
- •On-treatment participation on other clinical therapeutic trials
- •Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction))
- •Patients who have contraindication for MRI and CT with contrast agent (both)
- •Prior (> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage
- •History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease
研究组 & 干预措施
Control Arm
postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation
干预措施: RT standard of care (Radiation)
Investigational Arm
postoperative radiotherapy of the head and neck region without elective nodal irradiation
干预措施: Eliminating RT to the elective neck (Radiation)
结局指标
主要结局
Phase II: 1-year PEG feeding tube dependence rate
时间窗: PEG-dependent 1 year after radiotherapy
observe change of PEG-dependence due to different target volumes
Phase III: Time to local relapse
时间窗: From the date of randomization until the date of observation of local relapse or the date of last observation if no LR occurred, whichever came first (assessed up to 26 months)
difference between the date of randomization and the date of observation of local relapse (LR), or the date of last observation if no LR occurred (censored observation)
次要结局
- Distant-metastasis-free survival(through study completion, an average of 26 months)
- Cause of death (tumor-related, not tumor-related)(through study completion, an average of 26 months)
- Acute toxicity according to Common Terminology Criteria (CTC) version 5.0(up to 2 months)
- Late toxicity according to CTC version 5.0(up to 24 months)
- Overall survival (OS)(up to 26 months)
- Disease-free survival(up to 26 months)