Back to resultsEvaluation 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 (LAMBEAU STEPA)
Primary Purpose
Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oropharyngeal or oral cavity reconstruction
Sponsored by
About this trial
This is an interventional other trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer, STEPA flap, Oropharyngeal or oral cavity reconstruction, IDEAL Recommendations
Eligibility Criteria
Inclusion Criteria: Patient with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx. Patient whose disease is classified UICC TNM stade (8th edition) : T0-4a N0/N2c M0 (no distant metastasis M0). Patient whose oral cavity or oropharynx reconstruction requires a free fasciocutaneous flap according to an experienced oncology surgeon. Patient OMS 0-1. Age ≥ 18. Patient with no contraindication to surgery. Patient affiliated to a Social Health Insurance in France. 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: Patient with history of prior cervical surgery and/or radiation to the head and neck. History of pelvic surgery and/or radiation to the pelvic area. Patients with a contraindication to any form of sedation. Patient with irreversible coagulopathy. Patient with a contraindication to a CT scan or an injection of iodinated contrast medium. Patient with active autoimmune disorders requiring immunosuppressive therapy, defined as receiving steroids (dose > 10 mg of prednisone or equivalent) or other immunosuppressive therapy. Pregnant or breastfeeding women. 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. Patient with diabetes (type 1 or 2). Patient with a BMI > 30kg/m². 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 . Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Sites / Locations
- Chu Gui de Chauliac
- Centre Antoine Lacassagne
- Chu Purpan
- Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with an ORL Cancer
Arm Description
Outcomes
Primary Outcome Measures
The occurrence of a limiting complication. Limiting complications are defined as total flap necrosis (flap failure) or donor site infection (Fournier Gangrene) within 4 weeks of the experimental procedure.
Secondary Outcome Measures
The postoperative complications will be evaluated according to the NCI-CTCAE version n°5
The pain will be assessed according to a Likert scale between 0 (no pain) and 10 (worst pain).
The functional capacity of swallowing will be assessed via the Performance Status Scale for Head and Neck cancer patients - PSS-HN (Scales are: Normalcy of Diet, Public Eating, and Understandability of Speech).
4. The aesthetic evaluation will be performed according to a Likert scale (Likert scale: not at all satisfied, somewhat not satisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied).
Full Information
NCT ID
NCT05757817
First Posted
February 24, 2023
Last Updated
October 19, 2023
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT05757817
Brief 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
Acronym
LAMBEAU STEPA
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer
Keywords
Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer, STEPA flap, Oropharyngeal or oral cavity reconstruction, IDEAL Recommendations
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with an ORL Cancer
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Oropharyngeal or oral cavity reconstruction
Intervention 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.
Primary Outcome Measure Information:
Title
The occurrence of a limiting complication. Limiting complications are defined as total flap necrosis (flap failure) or donor site infection (Fournier Gangrene) within 4 weeks of the experimental procedure.
Time Frame
4 weeks for each patient
Secondary Outcome Measure Information:
Title
The postoperative complications will be evaluated according to the NCI-CTCAE version n°5
Time Frame
12 months for each patient
Title
The pain will be assessed according to a Likert scale between 0 (no pain) and 10 (worst pain).
Time Frame
12 months for each patient
Title
The functional capacity of swallowing will be assessed via the Performance Status Scale for Head and Neck cancer patients - PSS-HN (Scales are: Normalcy of Diet, Public Eating, and Understandability of Speech).
Time Frame
12 months for each patient
Title
4. The aesthetic evaluation will be performed according to a Likert scale (Likert scale: not at all satisfied, somewhat not satisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied).
Time Frame
12 months for each patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx.
Patient whose disease is classified UICC TNM stade (8th edition) : T0-4a N0/N2c M0 (no distant metastasis M0).
Patient whose oral cavity or oropharynx reconstruction requires a free fasciocutaneous flap according to an experienced oncology surgeon.
Patient OMS 0-1.
Age ≥ 18.
Patient with no contraindication to surgery.
Patient affiliated to a Social Health Insurance in France.
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:
Patient with history of prior cervical surgery and/or radiation to the head and neck.
History of pelvic surgery and/or radiation to the pelvic area.
Patients with a contraindication to any form of sedation.
Patient with irreversible coagulopathy.
Patient with a contraindication to a CT scan or an injection of iodinated contrast medium.
Patient with active autoimmune disorders requiring immunosuppressive therapy, defined as receiving steroids (dose > 10 mg of prednisone or equivalent) or other immunosuppressive therapy.
Pregnant or breastfeeding women.
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.
Patient with diabetes (type 1 or 2).
Patient with a BMI > 30kg/m².
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 .
Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès DUPRET-BORIES
Phone
05 31 15 53 08
Email
dupret-bories.agnes@iuct-oncopole.fr
Facility Information:
Facility Name
Chu Gui de Chauliac
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie DE BOUTRAY
Phone
04 67 33 80 77
Email
m-deboutray@chu-montpellier.fr
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre BOZEC
Phone
04 92 03 17 47
Email
alexandre.bozec@nice.unicancer.fr
Facility Name
Chu Purpan
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck DELANOE
Phone
05 61 77 22 33
Email
delanoe.f@chu-toulouse.fr
Facility Name
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnès DUPRET-BORIES
Phone
05 31 15 53 08
Email
Dupret-Bories.Agnes@iuct-oncopole.fr
12. IPD Sharing Statement
Learn more about this trial
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
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