Back to resultsStudy Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC (CURVE)
Primary Purpose
Oropharynx Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mandibular Reconstruction (MR) with Preoperative Virtual Planning (PVP).
Conventional Mandibular Reconstruction (MR without PVP)
Sponsored by
About this trial
This is an interventional supportive care trial for Oropharynx Squamous Cell Carcinoma focused on measuring fibula free-flap, mandibular reconstruction, preoperative virtual planning
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- CHU Groupe Hospitalier PellegrinRecruiting
- Centre Antoine Lacassagne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients undergoing PVP-assisted MR
Patients undergoing conventional (i.e. without PVP) MR
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
General Oral Health Assessment Index (GOHAI)
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.
Secondary Outcome Measures
Time between randomization and surgery
Mean and median time between randomization and surgery
Total operative time and flap ischemia time
Mean and median total operative time and mean and median flap ischemia time
Postoperative surgical complication rate (including free-flap failure rate)
Surgical complication rates defined as local complication requiring another intervention in the first postoperative month, including free-flap failure rates
Delayed surgical complication rate
Delayed surgical complication rates defined as local complication occurring after the first postoperative month: non-union (pseudo-arthrosis), osteosynthesis-associated infection…
Functional outcome: Performance Status Scales for Head and Neck (PSS-HN)
The PSS-HN is a 3-item scale designed to evaluate functional performance of H&N cancer patients, specifically Normalcy of Diet, Eating in Public, and Understandability of Speech. Each subscale is rated based on semi-structured interview with a score of 0 to 100, with higher scores indicating better performance. The subscale scores are reported separately, and the Normalcy of Diet subscale will be the primary score of interest for this trial.
The PSS-HN can be rated by health professionals including speech & language therapists and research nurses. The person collecting this data will remain consistent, as far as is feasible, throughout the course of the study. Scores are determined following an unstructured interview.
Functional outcome: Mouth opening range/capacity
Functional outcomes assessed by mouth opening range/capacity at baseline and at 1 year.
It will be performed by using a caliper square to measure in millimeters the inter-incisor gap, assessed by the investigator.
Functional outcome: MD Anderson Dysphagia Inventory (MDADI)
The MDADI is a self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the QoL of patients with head and neck cancer. It surveys QoL issues relevant to swallowing via several subscales: Emotional, Functional, and Physical. A fourth measurement, the Global subscale, is a single question designed to establish quickly an overall assessment that pertains to swallowing. A score ranging from 0 to 100 is calculated for each subscale, with higher scores indicating higher levels of dysphagia.
Functional outcome: Speech Handicap Index (SHI)
The SHI is a well-validated and widely used self-questionnaire for assessing speech problems in OOPC patients. It comprises 3 items and provides insight into the nature and severity of patients' complaints. Response categories for all but 1 item range on a 5-point scale (''never,'' ''almost never,'' ''sometimes,'' ''almost always,'' and ''always''). The questionnaire also includes an overall speech quality item, with 4 response categories (''good,'' ''reasonable,'' ''poor,'' and ''severe''). A total SHI score is calculated by summing all items (score range, 0-120), with higher scores indicating higher levels of speech related problems.
Functional dental status
Functional dental status (>6; 4-6, <4 functional dental units; type of dental rehabilitation) of the patients
Aesthetic outcome
Subjective assessment of the aesthetic outcome in the head and neck area using a visual analog scale (VAS) by the patient and the surgeon (assessed separately).
The AESTHETIC VAS is a validated, subjective measure for esthetical perception. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "very poor looking"(0) and "very nice looking" (10).
Morphological results: mandibular angle
Morphological results measured by the differences between the preoperative and postoperative measurements on 3D-CT-scan. The mandibular angle (in degrees) measured the amplitude of the angle existing between the ramus and body of the mandible.
Morphological results: bi-gonial diameter
Morphological results measured by the differences between the preoperative and postoperative measurements on 3D-CT-scan. The bi-gonial diameter (in millimeter), a measure of the contracture/reduction of the arch, is intended to measure the preservation of the native mandibular arch anatomy.
Morphological results: position of the gnathion
Morphological results measured by the differences between the preoperative and postoperative measurements on 3D-CT-scan. The lateral deviation (in millimeter) of gnathion in relation to the midsagittal plane will determined the degree of mandibular asymmetry.
Pain in the head and neck area
"no pain" (0) and "worst pain" (10).
Evolution of patient QoL: GOHAI score
Evolution of patient QoL GOHAI score at 6 months (this score will be compared to the score measured at baseline and at 1 year).
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.
Evolution of patient QoL: Quality of life questionnaire - Core 30 (QLQ-C30) score
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The EORTC QLQ-C30 is a general self-report questionnaire designed to assess QoL in cancer patients. It consists of five functioning scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea, and vomiting), a global QoL scale, and six single questions assessing additional symptoms commonly reported by cancer patients.
As recommended by the EORTC, the scales and single-item variables of the QLQ-C30 will be linearly transformed into a score from 0 to 100. A high score for a functioning scale and for the global QOL scale represents a better level of functioning, whereas a high score for a symptom scale or a single item scale denotes a high level of symptoms or problems.
Evolution of patient QoL: Quality of Life Questionnaire - Head & Neck Cancer Module (QLQ-H&N35) score
The EORTC QLQ-H&N35 is a tumor specific self-report questionnaire for head and neck cancer patients including seven symptoms scales (pain, swallowing, senses, speech, social eating, social contacts, and sexuality) and six single items (teeth problems, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill).
As recommended by the EORTC, the scales and single-item variables of the H&N35 questionnaire will be linearly transformed into a score from 0 to 100. A high score for a functioning scale and for the global QOL scale represents a better level of functioning, whereas a high score for a symptom scale or a single item scale denotes a high level of symptoms or problems.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04725396
Brief Title
Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC
Acronym
CURVE
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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]).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharynx Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma
Keywords
fibula free-flap, mandibular reconstruction, preoperative virtual planning
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing PVP-assisted MR
Arm Type
Experimental
Arm Description
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).
Arm Title
Patients undergoing conventional (i.e. without PVP) MR
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mandibular Reconstruction (MR) with Preoperative Virtual Planning (PVP).
Intervention Description
PVP-assisted mandibular reconstruction 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).
Intervention Type
Device
Intervention Name(s)
Conventional Mandibular Reconstruction (MR without PVP)
Intervention Description
Conventional Mandibular Reconstruction
Primary Outcome Measure Information:
Title
General Oral Health Assessment Index (GOHAI)
Description
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.
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Time between randomization and surgery
Description
Mean and median time between randomization and surgery
Time Frame
At the time of surgery, up to 45 days after randomization
Title
Total operative time and flap ischemia time
Description
Mean and median total operative time and mean and median flap ischemia time
Time Frame
Post surgery, up to 45 days after randomization
Title
Postoperative surgical complication rate (including free-flap failure rate)
Description
Surgical complication rates defined as local complication requiring another intervention in the first postoperative month, including free-flap failure rates
Time Frame
Post surgery, up to 45 days after randomization
Title
Delayed surgical complication rate
Description
Delayed surgical complication rates defined as local complication occurring after the first postoperative month: non-union (pseudo-arthrosis), osteosynthesis-associated infection…
Time Frame
Post surgery, up to 45 days after randomization
Title
Functional outcome: Performance Status Scales for Head and Neck (PSS-HN)
Description
The PSS-HN is a 3-item scale designed to evaluate functional performance of H&N cancer patients, specifically Normalcy of Diet, Eating in Public, and Understandability of Speech. Each subscale is rated based on semi-structured interview with a score of 0 to 100, with higher scores indicating better performance. The subscale scores are reported separately, and the Normalcy of Diet subscale will be the primary score of interest for this trial.
The PSS-HN can be rated by health professionals including speech & language therapists and research nurses. The person collecting this data will remain consistent, as far as is feasible, throughout the course of the study. Scores are determined following an unstructured interview.
Time Frame
At baseline and at 1 year
Title
Functional outcome: Mouth opening range/capacity
Description
Functional outcomes assessed by mouth opening range/capacity at baseline and at 1 year.
It will be performed by using a caliper square to measure in millimeters the inter-incisor gap, assessed by the investigator.
Time Frame
At baseline and at 1 year
Title
Functional outcome: MD Anderson Dysphagia Inventory (MDADI)
Description
The MDADI is a self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the QoL of patients with head and neck cancer. It surveys QoL issues relevant to swallowing via several subscales: Emotional, Functional, and Physical. A fourth measurement, the Global subscale, is a single question designed to establish quickly an overall assessment that pertains to swallowing. A score ranging from 0 to 100 is calculated for each subscale, with higher scores indicating higher levels of dysphagia.
Time Frame
1 year
Title
Functional outcome: Speech Handicap Index (SHI)
Description
The SHI is a well-validated and widely used self-questionnaire for assessing speech problems in OOPC patients. It comprises 3 items and provides insight into the nature and severity of patients' complaints. Response categories for all but 1 item range on a 5-point scale (''never,'' ''almost never,'' ''sometimes,'' ''almost always,'' and ''always''). The questionnaire also includes an overall speech quality item, with 4 response categories (''good,'' ''reasonable,'' ''poor,'' and ''severe''). A total SHI score is calculated by summing all items (score range, 0-120), with higher scores indicating higher levels of speech related problems.
Time Frame
1 year
Title
Functional dental status
Description
Functional dental status (>6; 4-6, <4 functional dental units; type of dental rehabilitation) of the patients
Time Frame
At baseline and at 1 year
Title
Aesthetic outcome
Description
Subjective assessment of the aesthetic outcome in the head and neck area using a visual analog scale (VAS) by the patient and the surgeon (assessed separately).
The AESTHETIC VAS is a validated, subjective measure for esthetical perception. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "very poor looking"(0) and "very nice looking" (10).
Time Frame
1 year
Title
Morphological results: mandibular angle
Description
Morphological results measured by the differences between the preoperative and postoperative measurements on 3D-CT-scan. The mandibular angle (in degrees) measured the amplitude of the angle existing between the ramus and body of the mandible.
Time Frame
At 1 year
Title
Morphological results: bi-gonial diameter
Description
Morphological results measured by the differences between the preoperative and postoperative measurements on 3D-CT-scan. The bi-gonial diameter (in millimeter), a measure of the contracture/reduction of the arch, is intended to measure the preservation of the native mandibular arch anatomy.
Time Frame
At 1 year
Title
Morphological results: position of the gnathion
Description
Morphological results measured by the differences between the preoperative and postoperative measurements on 3D-CT-scan. The lateral deviation (in millimeter) of gnathion in relation to the midsagittal plane will determined the degree of mandibular asymmetry.
Time Frame
At 1 year
Title
Pain in the head and neck area
Description
"no pain" (0) and "worst pain" (10).
Time Frame
At 1 year
Title
Evolution of patient QoL: GOHAI score
Description
Evolution of patient QoL GOHAI score at 6 months (this score will be compared to the score measured at baseline and at 1 year).
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.
Time Frame
At baseline, at 6 months, and at 1 year
Title
Evolution of patient QoL: Quality of life questionnaire - Core 30 (QLQ-C30) score
Description
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The EORTC QLQ-C30 is a general self-report questionnaire designed to assess QoL in cancer patients. It consists of five functioning scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea, and vomiting), a global QoL scale, and six single questions assessing additional symptoms commonly reported by cancer patients.
As recommended by the EORTC, the scales and single-item variables of the QLQ-C30 will be linearly transformed into a score from 0 to 100. A high score for a functioning scale and for the global QOL scale represents a better level of functioning, whereas a high score for a symptom scale or a single item scale denotes a high level of symptoms or problems.
Time Frame
At baseline, at 6 months and at 1 year.
Title
Evolution of patient QoL: Quality of Life Questionnaire - Head & Neck Cancer Module (QLQ-H&N35) score
Description
The EORTC QLQ-H&N35 is a tumor specific self-report questionnaire for head and neck cancer patients including seven symptoms scales (pain, swallowing, senses, speech, social eating, social contacts, and sexuality) and six single items (teeth problems, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill).
As recommended by the EORTC, the scales and single-item variables of the H&N35 questionnaire will be linearly transformed into a score from 0 to 100. A high score for a functioning scale and for the global QOL scale represents a better level of functioning, whereas a high score for a symptom scale or a single item scale denotes a high level of symptoms or problems.
Time Frame
At baseline, at 6 months and at 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florence GARIC
Phone
+33760057454
Email
f-garic@unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laure MONARD
Email
l-monard@unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre BOZEC
Organizational Affiliation
Centre Antoine Lacassagne Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire MAJOUFRE, Pr
Email
claire.majoufre@chu-bordeaux.fr
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06 103
Country
France
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC
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