A Randomized Prospective Multicenter Study Comparing Fibula Free-flap Mandibular Reconstruction With or Without Preoperative Virtual Planning in Patients With Oral or Oropharyngeal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 132
- 试验地点
- 12
- 主要终点
- General Oral Health Assessment Index (GOHAI)
研究概览
简要总结
This is a national multicenter, randomized, stratified, open label study, aiming to compare mandibular reconstruction (MR) with or without preoperative virtual planning (PVP), in patients with oral/oropharyngeal cancer (OOPC).
详细描述
PVP-assisted MR includes the production of the surgical cutting guides required for mandibular resection and fibula free-flap conformation and of the preformed plates for flap osteosynthesis (for all patients, PVP will be done by the same laboratory: Materialise laboratory).
PVP-assisted MR includes the production of :
- surgical cutting guides required for mandibular resection and fibula free-flap conformation
- preformed plates for flap osteosynthesis
Patients will be selected after the multidisciplinary decision of oncological surgery including segmental mandibulectomy and immediate MR. Patients will be randomized in 2 groups (ratio 1:1, stratified on center and tumor N status [0-1 vs 2-3]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Aged 18 years or over
- •Primary or recurrent OOPC, histologically proven, requiring segmental mandibulectomy
- •Planned immediate fibula free flap MR to be performed at the same time as the tumor ablation by segmental mandibulectomy
- •MR requiring at least one osteotomy for contouring the flap (i.e. at least 2 bone fragments)
- •East Cooperative Oncology Group (ECOG) performance status 0 or 1
- •American Society of Anesthesiologists Physical Status (ASA) score 1, 2, or 3
- •Patients considered fit for surgery as decided by the multidisciplinary team
- •Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
- •Patients must be affiliated to a Social Security System (or equivalent)
- •Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their written consent, a trusted person of their choice, not related to the investigator or the sponsor, can confirm in writing the patient's consent
排除标准
- •Non resectable tumors (T4b primary tumor, non resectable metastatic lymph nodes)
- •Comorbidities factors that would contraindicate surgery (such as severe peripheral artery disease)
- •MR requiring no osteotomy for contouring the flap (i.e. one bone fragment)
- •Patients with distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or positron emission tomography (PET)-CT
- •Other uncontrolled malignancy
- •Serious, non-healing or dehiscing wound, active ulcer or ongoing bone fracture at the free-flap donor site
- •Patients unwilling or unable to comply with the medical follow-up required by the trial because of psychosocial, familial, social, or geographical reasons
- •Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion
- •Patients deprived of their liberty or under protective custody or guardianship
结局指标
主要结局
General Oral Health Assessment Index (GOHAI)
时间窗: 1-year
Oral health-related quality of life (QoL) measured 1 year after surgery using the GOHAI in the 2 groups of patients (MR with or without PVP). The GOHAI is an oral-disease-specific QoL measure made by the patient. The GOHAI comprises 12 items grouped into three dimensions: the functional dimension (eating, speaking, swallowing); the pain or discomfort dimension (drugs, gingival sensitivity, discomfort when chewing certain foods); and, the psychosocial dimension (concerns, relational discomfort, appearance). The response format for each item is based on a five-point Likert scale: always = 1; often = 2; sometimes = 3; seldom = 4; never = 5. A summary score (ranging from 0 to 60) is calculated for each patient with a higher score indicating better oral health. GOHAI scores close to 30 have been reported in head and neck cancer patients after oncologic surgery and pedicled or free flap reconstruction.
次要结局
- Total operative time and flap ischemia time(Post surgery, up to 45 days after randomization)
- Postoperative surgical complication rate (including free-flap failure rate)(Post surgery, up to 45 days after randomization)
- Delayed surgical complication rate(Post surgery, up to 45 days after randomization)
- Pain in the head and neck area(At 1 year)
- Time between randomization and surgery(At the time of surgery, up to 45 days after randomization)
- Functional outcome: Performance Status Scales for Head and Neck (PSS-HN)(At baseline and at 1 year)
- Functional outcome: Mouth opening range/capacity(At baseline and at 1 year)
- Functional outcome: MD Anderson Dysphagia Inventory (MDADI)(1 year)
- Functional outcome: Speech Handicap Index (SHI)(1 year)
- Functional dental status(At baseline and at 1 year)
- Aesthetic outcome(1 year)
- Morphological results: mandibular angle(At 1 year)
- Morphological results: bi-gonial diameter(At 1 year)
- Morphological results: position of the gnathion(At 1 year)
- Evolution of patient QoL: GOHAI score(At baseline, at 6 months, and at 1 year)
- Evolution of patient QoL: Quality of life questionnaire - Core 30 (QLQ-C30) score(At baseline, at 6 months and at 1 year.)
- Evolution of patient QoL: Quality of Life Questionnaire - Head & Neck Cancer Module (QLQ-H&N35) score(At baseline, at 6 months and at 1 year.)
- Time between randomization and surgery(At the time of surgery, up to 45 days after randomization)
- Total operative time and flap ischemia time(Post surgery, up to 45 days after randomization)
- Postoperative surgical complication rate (including free-flap failure rate)(Post surgery, up to 45 days after randomization)
- Delayed surgical complication rate(Post surgery, up to 45 days after randomization)
- Functional outcome: Performance Status Scales for Head and Neck (PSS-HN)(At baseline and at 1 year)
- Functional outcome: Mouth opening range/capacity(At baseline and at 1 year)
- Functional outcome: MD Anderson Dysphagia Inventory (MDADI)(1 year)
- Functional outcome: Speech Handicap Index (SHI)(1 year)
- Functional dental status(At baseline and at 1 year)
- Aesthetic outcome(1 year)
- Morphological results: mandibular angle(At 1 year)
- Morphological results: bi-gonial diameter(At 1 year)
- Evolution of patient QoL: Quality of Life Questionnaire - Head & Neck Cancer Module (QLQ-H&N35) score(At baseline, at 6 months and at 1 year.)
- Morphological results: position of the gnathion(At 1 year)
- Pain in the head and neck area(At 1 year)
- Evolution of patient QoL: GOHAI score(At baseline, at 6 months, and at 1 year)
- Evolution of patient QoL: Quality of life questionnaire - Core 30 (QLQ-C30) score(At baseline, at 6 months and at 1 year.)