New surgical procedure for reconstructing the oral cavity and oropharynx in cancer patients

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

This study is testing a new surgical method using a special tissue flap to see if it can safely help cancer patients who need reconstruction in their mouth and throat areas.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Claudius Regaud (other)
• Drugs / interventions: radiation, prednisone
• Locations: 4 sites (Montpellier and 3 other locations)
• Trial ID: NCT05757817 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and feasibility of using the external pudendal free flap for reconstructive surgery in patients with head and neck cancers, specifically targeting the oral cavity and oropharynx. It consists of two phases: the innovation phase (IDEAL-1), which assesses the feasibility of the procedure, and the prospective development phase (IDEAL-2A), which describes the complication profile of the surgery. A total of 40 patients will be enrolled, with each patient followed for 12 months post-treatment to monitor outcomes and complications.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of head and neck squamous cell carcinoma requiring reconstructive surgery.

Not a fit: Patients with a history of prior cervical or pelvic surgery, or those with contraindications to surgery or sedation, may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could reduce surgical complications and improve recovery for patients undergoing reconstruction after head and neck cancer treatment.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in reconstructive techniques, suggesting potential for success.

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).

Where this trial is running

Montpellier and 3 other locations

• 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)

Study contacts

• Study coordinator: Agnès DUPRET-BORIES

Conditions: Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer, STEPA flap, Oropharyngeal or oral cavity reconstruction, IDEAL Recommendations