Phase III Trial Testing the Benefit of Intensity-modulated Radiotherapy With Weekly Replanifications Versus Intensity Modulated Radiotherapy With Only One Planification in Locally Advanced Oropharynx Carcinoma for Decreasing Xerostomia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 18
- 主要终点
- Salivary flow measure
研究概览
简要总结
The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)
- •Age ≥ 18 years and ≤ 75 years
- •Performance status (WHO ≤ 2)
- •Renal, hepatic and cardiovascular functions allowing systemic treatment administration
- •Adapted stomatologic care
- •Signed informed consent form
- •Membership or beneficiary of a national insurance scheme
排除标准
- •Both parotids totally included in the target volume
- •Stages T1 or T2 with positive node disease N1
- •Neoadjuvant chemotherapy
- •Exereses of primitive tumor and/or nodes
- •History of other cancer within 5 years (except for basocellular epithelioma and cervical)
- •Previous neck radiotherapy
- •Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy considerations
- •Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia)incompatible with study participation
- •Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.
- •Patient already recruited in another biomedical research ( non interventional study is authorized)
- •Pregnant or breast feeding patients
- •Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection
- •Patient is deemed incapable of giving informed consent
- •Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.
结局指标
主要结局
Salivary flow measure
时间窗: 12 months after the end of radiotherapy
The salivary flow is measured after stimulation with Parafilm at the time of inclusion and then 12 months after the end of radiotherapy.
次要结局
- Xerostomia(From before treatment to 24 months after the end of radiotherapy)
- Salivary flow(Before treatment and 12 months after the end of radiotherapy)
- Survival(2 years)
- Local control(2 years)
- Early and late toxicities(From beginning of the radiotherapy up to 2 years after the end of radiotherapy)
- Head and Neck functionality(Before treatment to 24 months after the end of radiotherapy)