Clinical trial NCT04725396: Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC
Official title: A Randomized Prospective Multicenter Study Comparing Fibula Free-flap Mandibular Reconstruction With or Without Preoperative Virtual Planning in Patients With Oral or Oropharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oropharynx Squamous Cell Carcinoma
Oral Cavity Squamous Cell Carcinoma
Keywords: fibula free-flap
mandibular reconstruction
preoperative virtual planning
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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 \[0-1 vs 2-3\]).

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or over
2. Primary or recurrent OOPC, histologically proven, requiring segmental mandibulectomy
3. Planned immediate fibula free flap MR to be performed at the same time as the tumor ablation by segmental mandibulectomy
4. MR requiring at least one osteotomy for contouring the flap (i.e. at least 2 bone fragments)
5. East Cooperative Oncology Group (ECOG) performance status 0 or 1
6. American Society of Anesthesiologists Physical Status (ASA) score 1, 2, or 3
7. Patients considered fit for surgery as decided by the multidisciplinary team
8. 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
9. Patients must be affiliated to a Social Security System (or equivalent)
10. 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

Exclusion Criteria:

1. Non resectable tumors (T4b primary tumor, non resectable metastatic lymph nodes)
2. Comorbidities factors that would contraindicate surgery (such as severe peripheral artery disease)
3. MR requiring no osteotomy for contouring the flap (i.e. one bone fragment)
4. 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
5. Other uncontrolled malignancy
6. Serious, non-healing or dehiscing wound, active ulcer or ongoing bone fracture at the free-flap donor site
7. Patients unwilling or unable to comply with the medical follow-up required by the trial because of psychosocial, familial, social, or geographical reasons
8. Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion
9. Patients deprived of their liberty or under protective custody or guardianship

Primary outcomes:
measure: General Oral Health Assessment Index (GOHAI)
timeFrame: 1-year
Secondary outcomes:
measure: Time between randomization and surgery
timeFrame: At the time of surgery, up to 45 days after randomization
measure: Total operative time and flap ischemia time
timeFrame: Post surgery, up to 45 days after randomization
measure: Postoperative surgical complication rate (including free-flap failure rate)
timeFrame: Post surgery, up to 45 days after randomization
measure: Delayed surgical complication rate
timeFrame: Post surgery, up to 45 days after randomization
measure: Functional outcome: Performance Status Scales for Head and Neck (PSS-HN)
timeFrame: At baseline and at 1 year
measure: Functional outcome: Mouth opening range/capacity
timeFrame: At baseline and at 1 year
measure: Functional outcome: MD Anderson Dysphagia Inventory (MDADI)
timeFrame: 1 year
measure: Functional outcome: Speech Handicap Index (SHI)
timeFrame: 1 year
measure: Functional dental status
timeFrame: At baseline and at 1 year
measure: Aesthetic outcome
timeFrame: 1 year
measure: Morphological results: mandibular angle
timeFrame: At 1 year
measure: Morphological results: bi-gonial diameter
timeFrame: At 1 year
measure: Morphological results: position of the gnathion
timeFrame: At 1 year
measure: Pain in the head and neck area
timeFrame: At 1 year
measure: Evolution of patient QoL: GOHAI score
timeFrame: At baseline, at 6 months, and at 1 year
measure: Evolution of patient QoL: Quality of life questionnaire - Core 30 (QLQ-C30) score
timeFrame: At baseline, at 6 months and at 1 year.
measure: Evolution of patient QoL: Quality of Life Questionnaire - Head & Neck Cancer Module (QLQ-H&N35) score
timeFrame: At baseline, at 6 months and at 1 year.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Groupe Hospitalier Pellegrin
city: Caen
country: France
facility: Centre François Baclesse
city: Lille
country: France
facility: Centre Oscar Lambret
city: Montpellier
country: France
facility: CHU Gui de Chauliac
city: Nantes
country: France
facility: CHU Hotel Dieu
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Rennes
country: France
facility: CHU Pontchaillou
city: Toulouse
country: France
facility: IUCT-O
city: Valenciennes
country: France
facility: CHR de Valenciennes
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Centre Antoine Lacassagne Nice
name: Alexandre BOZEC
role: PRINCIPAL_INVESTIGATOR
References: