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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05757817
Other study ID # 22VADS02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 8, 2023
Est. completion date January 2027

Study information

Verified date December 2023
Source Institut Claudius Regaud
Contact Agnès DUPRET-BORIES
Phone 05 31 15 53 08
Email dupret-bories.agnes@iuct-oncopole.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 2027
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Procedure:
Oropharyngeal or oral cavity reconstruction
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.

Locations

Country Name City State
France Chu Gui de Chauliac Montpellier
France Centre Antoine Lacassagne Nice
France Chu Purpan Toulouse
France Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O) Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks for each patient
Secondary The postoperative complications will be evaluated according to the NCI-CTCAE version n°5 12 months for each patient
Secondary The pain will be assessed according to a Likert scale between 0 (no pain) and 10 (worst pain). 12 months for each patient
Secondary 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). 12 months for each patient
Secondary 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). 12 months for each patient
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