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
- 10
- 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
研究组 & 干预措施
Patients undergoing PVP-assisted MR
PVP is based on CT-scan with millimetric thin slice acquisitions of the facial bone and fibulas. The surgeon defines the exact sites of the intended mandibular osteotomies. A single external subcontracted laboratory (Materialise®) produces the various cutting guides for mandibular resection, flap conformation and the preformed plates for flap osteosynthesis. Flap conformation is entirely performed at the donor site before section of the vascular pedicle (flap still vascularized).
干预措施: Mandibular Reconstruction (MR) with Preoperative Virtual Planning (PVP). (Device)
Patients undergoing conventional (i.e. without PVP) MR
Flap modeling and positioning requires one or multiple cuneiform osteotomies. The bone transplant is shaped to restore the contours of the mandibular defect using preoperative imaging studies and the resection specimen. Flap conformation begins at the donor site and is generally completed at the recipient site after fibular pedicle section and before microvascular anastomosis (during ischemia time). The different bone fragments are fixed together and to the native mandible using either titanium miniplates or reconstruction plate and monocortical screws. Regardless of the material used for fixing the fibular flap to the native mandible, the use of a reconstruction plate adapted to the native mandible (or other similar techniques) prior to tumor resection is recommended to guide flap shaping and positioning, and to insure an accurate MR.
干预措施: Conventional Mandibular Reconstruction (MR without PVP) (Device)
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.)