Head and Neck CancerLAMBEAU STEPANCT05757817
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
A study testing Oropharyngeal or oral cavity reconstruction in people with Head and Neck Cancer and Oral Cavity Cancer, run by Institut Claudius Regaud at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer
- What is being tested?
- Oropharyngeal or oral cavity reconstruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Nov 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Chu Gui de Chauliac
Montpellier
Marie DE BOUTRAY, 04 67 33 80 77, m-deboutray@chu-montpellier.fr
- Recruiting
Centre Antoine Lacassagne
Nice
Alexandre BOZEC, 04 92 03 17 47, alexandre.bozec@nice.unicancer.fr
- Not yet recruiting
Chu Purpan
Toulouse
Franck DELANOE, 05 61 77 22 33, delanoe.f@chu-toulouse.fr
- Recruiting
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Toulouse
Agnès DUPRET-BORIES, 05 31 15 53 08, Dupret-Bories.Agnes@iuct-oncopole.fr
About this study
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.
Read more
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.
- Conditions
- Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer
- Being tested
- Oropharyngeal or oral cavity reconstruction
- Keywords
- Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer, STEPA flap, Oropharyngeal or oral cavity reconstruction, IDEAL Recommendations
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal or oral cavity reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with an ORL Cancer | Experimental | Not described Receives: Procedure: Oropharyngeal or oral cavity reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks for each patient
Secondary outcomes (4)
The postoperative complications will be evaluated according to the NCI-CTCAE version n°5
Measured: 12 months for each patient
The pain will be assessed according to a Likert scale between 0 (no pain) and 10 (worst pain).
Measured: 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).
Measured: 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).
Measured: 12 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start8 Nov 2023
- Primary completionMay 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757817
- Sponsor's protocol ID
- 22VADS02
- Acronym
- LAMBEAU STEPA
- Status last verified
- Sep 2025
- First submitted
- 24 Feb 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05757817
- Acronym / sponsor ID
- LAMBEAU STEPA / 22VADS02
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with an ORL Cancer | Experimental | Procedure: Oropharyngeal or oral cavity reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oropharyngeal or oral cavity reconstructionOropharyngeal 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. | Procedure or surgery | Patient with an ORL Cancer |
Primary outcome
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
4 secondary outcomes
The postoperative complications will be evaluated according to the NCI-CTCAE version n°5
Time frame: 12 months for each patient
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oropharyngeal or oral cavity reconstruction in people with Head and Neck Cancer and Oral Cavity Cancer, run by Institut Claudius Regaud at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnès DUPRET-BORIES (05 31 15 53 08, dupret-bories.agnes@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.