2024-513977-31-00招募中2 期
A phase II trial of radiotherapy-durvalumab without prophylactic neck irradiation in squamous cell carcinoma of the head and neck (REWRITe)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 61
- 试验地点
- 19
- 主要终点
- Regional (neck) nodal control rate at 1 year
研究概览
简要总结
To evaluate the regional (cervical) control of durvalumab treatment combined with radiotherapy to the tumor site including the primary tumor and the invaded cervical lymph nodes and the 1st lymph node level, without prophylactic irradiation of the N0 regions in patients with T1-T4 N0-N2b squamous cell carcinoma of the head and neck.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years with no upper limit
- •Performance Status ECOG 0-2
- •Squamous cell carcinoma, previously untreated
- •T1-T4 with clinical status N0-N1, N2a or N2b non palpable, with only homolateral lymph node in radiological examinations.
- •Patient with at least one of these fragility criteria : o Status ECOG 1 with multiple comorbidities, at least 2 pathologies with grade ≥ 2 (renal and/or cardiac and/or vascular and/or hepatic, and/or neurologic, and/or pulmonary) o Status ECOG = 2 o Age ≥ 70 , judged unfit with oncogeriatric evaluation by EGE (ELAN Geriatric Evaluation) test or unable to receive cisplatine or Carboplatine- 5FU (at least one criteria listed below*) * Criteria for determining if a patient is unfit for receiving cisplatine or carbo-5FU : Calculated creatinine clearance ≤ 60 mL/min as determined by the modified. method of Cockcroft and Gault or glomerular filtration rate ≤ 60 mL/min/1.73m² (CKD-EPI method recommended) Haemoglobin < 10 g/dL, aspartate (AST) and alanine transaminase (ALT) more than 2 times the upper limit of the normal range (ULN), serum albumin ≤35 g/L, Absolute neutrophil count ≤ 1 500/μL, platelets ≤ 100 000/μL or total bilirubin ≥ 1.5 mg/dL Cardiac function not compatible with hyperhydration or significant heart disease Weight loss > 15% in 2 months
- •Oral cavity, oropharynx, hypopharynx or larynx
- •Documentation of p16 disease (HPV status for oropharyngeal tumor)
- •Glomerular filtration rate (GFR) >40 mL/min/1.73m2 (CKD-EPI method recommended) or Calculated creatinine clearance CL>40 mL/min by the Cockcroft- Gault formula
排除标准
- •Nasopharyngeal, paranasal sinuses, nasal cavity tumors or thyroid cancers
- •Metastatic disease
- •Any prior or current treatment for invasive head and neck cancer
- •Any unresolved toxicity NCI CTCAE v5.0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. a. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis b. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the investigator
- •Body weight ≤ 30 kg and/or weight loss of ≥ 15% during the last 4 weeks (except if renutrition with a feeding tube is planned before the onset of treatment or is ongoing)
- •Other severe acute or chronic medical conditions including pneumonitis, pulmonary fibrosis
- •Active autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc])
- •Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
结局指标
主要结局
Regional (neck) nodal control rate at 1 year
Regional (neck) nodal control rate at 1 year
次要结局
- Early and late adverse events of grade ≥ 2, according to the CTCAE V5.0
- Local control at the primary site
- Locoregional nodal + primary site control rate
- Distant metastases control rate
- Ultimate regional control including salvage surgery and/or salvage RT)
- Overall survival
- Objective Response Rate
- Progression-free survival
- QLQ C30 and QLQ-H&N35 scores at baseline, 3, 12 and 24 months post RT
研究者
Dr Joël CASTELLI
Scientific
Groupe Oncologie Radiotherapie Tete Cou
研究点 (19)
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