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Trial Title:
Evaluation of the Benefit of a New Surgical Procedure According to IDEAL Recommendations for ORL Cancer Patients: the External Pudendal Flap Used as a New Free Flap for Oral Cavity/Oropharyngeal Reconstruction to Limit Donor Site Sequelae
NCT ID:
NCT05757817
Condition:
Head and Neck Cancer
Oral Cavity Cancer
Oropharynx Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Mouth Neoplasms
Oropharyngeal Neoplasms
Conditions: Keywords:
Head and Neck Cancer
Oral Cavity Cancer
Oropharynx Cancer
STEPA flap
Oropharyngeal or oral cavity reconstruction
IDEAL Recommendations
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Oropharyngeal or oral cavity reconstruction
Description:
Oropharyngeal or oral cavity reconstruction will be performed using a free super thin
external pudendal artery flap (STEPA flap).
Post-operative follow-up and adjuvant treatment: Post-operative follow-up of patients
will be performed according to the standards of the participating centers.
Arm group label:
Patient with an ORL Cancer
Summary:
This is a phase 1b, multicenter, non-randomized prospective study involving an innovation
phase (IDEAL-1) followed by a prospective development phase (IDEAL-2A) designed to
evaluate the safety and feasibility of oral/oropharyngeal reconstruction with the
external pudendal free flap in two groups of patients.
A maximum of 40 patients (20 patients per group) will be included in this IDEAL-1/2A
phase study.
Stage IDEAL-1: Innovation phase. The main objective is to evaluate the feasibility in
terms of limiting surgical complications of a STEPA flap reconstruction in two groups of
patients (Cohort: Male, Female).
Stage IDEAL-2A: Prospective development phase. The main objective is to describe the
complication profile of the surgical procedure in these two patient populations.
Each patient will be followed during 12 months after the end of complete treatment
(surgery ± adjuvant treatment).
A complementary study (observational study) of 250 patients will also be conducted to
evaluate the acceptability of the technique (reconstruction by external pudendal flap) by
the patients and to describe the factors associated with this acceptability.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient with a histologically proven diagnosis of head and neck squamous cell
carcinoma (HNSCC) of the oral cavity or oropharynx.
2. Patient whose disease is classified UICC TNM stade (8th edition) : T0-4a N0/N2c M0
(no distant metastasis M0).
3. Patient whose oral cavity or oropharynx reconstruction requires a free
fasciocutaneous flap according to an experienced oncology surgeon.
4. Patient OMS 0-1.
5. Age ≥ 18.
6. Patient with no contraindication to surgery.
7. Patient affiliated to a Social Health Insurance in France.
8. Patient able to participate and willing to give informed consent prior performance
of any study-related procedures and to comply with the study protocol.
Exclusion Criteria:
1. Patient with history of prior cervical surgery and/or radiation to the head and
neck.
2. History of pelvic surgery and/or radiation to the pelvic area.
3. Patients with a contraindication to any form of sedation.
4. Patient with irreversible coagulopathy.
5. Patient with a contraindication to a CT scan or an injection of iodinated contrast
medium.
6. Patient with active autoimmune disorders requiring immunosuppressive therapy,
defined as receiving steroids (dose > 10 mg of prednisone or equivalent) or other
immunosuppressive therapy.
7. Pregnant or breastfeeding women.
8. Patient with another co-existing malignancy at the time of inclusion or any other
significant medical, psychiatric, or surgical condition currently not controlled by
treatment, which may interfere with the conduct of the study.
9. Patient with diabetes (type 1 or 2).
10. Patient with a BMI > 30kg/m².
11. Any psychological, family, geographic or sociological condition that does not allow
for compliance with the medical follow-up and/or procedures provided for in the
study protocol .
12. Patient who has forfeited his/her freedom by administrative or legal award or who is
under legal protection (curatorship and guardianship, protection of justice).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chu Gui de Chauliac
Address:
City:
Montpellier
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marie DE BOUTRAY
Phone:
04 67 33 80 77
Email:
m-deboutray@chu-montpellier.fr
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Country:
France
Status:
Recruiting
Contact:
Last name:
Alexandre BOZEC
Phone:
04 92 03 17 47
Email:
alexandre.bozec@nice.unicancer.fr
Facility:
Name:
Chu Purpan
Address:
City:
Toulouse
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Franck DELANOE
Phone:
05 61 77 22 33
Email:
delanoe.f@chu-toulouse.fr
Facility:
Name:
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Agnès DUPRET-BORIES
Phone:
05 31 15 53 08
Email:
Dupret-Bories.Agnes@iuct-oncopole.fr
Start date:
November 8, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
Institut Claudius Regaud
Agency class:
Other
Source:
Institut Claudius Regaud
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05757817
