Informations générales (source: ClinicalTrials.gov)
A Randomized Prospective Multicenter Study Comparing Fibula Free-flap Mandibular Reconstruction With or Without Preoperative Virtual Planning in Patients With Oral or Oropharyngeal Cancer
Interventional
N/A
UNICANCER (Voir sur ClinicalTrials)
avril 2021
septembre 2025
29 août 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Nadia BENMOUSSA-REBIBO | 30/05/2024 12:07:20 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - Lille - France | Contact (sur clinicalTrials) | ||||
| CHR de Valenciennes - Valenciennes - France | Contact (sur clinicalTrials) | ||||
| CHU Groupe Hospitalier Pellegrin - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU Gui de Chauliac - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU Hotel Dieu - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHU Pontchaillou - Rennes - France | Contact (sur clinicalTrials) | ||||
| Gustave Roussy - Villejuif - France | Contact (sur clinicalTrials) | ||||
| IUCT-O - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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