NCT05757817

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
8mo left

Started Nov 2023

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Nov 2023Jan 2027

First Submitted

Initial submission to the registry

February 24, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

February 24, 2023

Last Update Submit

September 11, 2025

Conditions

Head and Neck CancerOral Cavity CancerOropharynx Cancer

Keywords

Head and Neck CancerOral Cavity CancerOropharynx CancerSTEPA flapOropharyngeal or oral cavity reconstructionIDEAL Recommendations

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The postoperative complications will be evaluated according to the NCI-CTCAE version n°5

    12 months for each patient

  • The pain will be assessed according to a Likert scale between 0 (no pain) and 10 (worst pain).

    12 months for each patient

  • 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

  • 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

Study Arms (1)

Patient with an ORL Cancer

EXPERIMENTAL
Procedure: Oropharyngeal or oral cavity reconstruction

Interventions

Oropharyngeal or oral cavity reconstructionPROCEDURE

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.

Patient with an ORL Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chu Gui de Chauliac

Montpellier, France

NOT YET RECRUITING

Centre Antoine Lacassagne

Nice, France

RECRUITING

Chu Purpan

Toulouse, France

NOT YET RECRUITING

Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsMouth NeoplasmsOropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Agnès DUPRET-BORIES

CONTACT

05 31 15 53 08dupret-bories.agnes@iuct-oncopole.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 7, 2023

Study Start

November 8, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations

FR(4)