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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Antoine Lacassagne
  Nice, France Recruiting
• Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
  Toulouse, France Recruiting
• Chu Gui de Chauliac
  Montpellier, France Not yet recruiting
• Chu Purpan
  Toulouse, France Not yet recruiting

Study contacts

• Study coordinator: Agnès DUPRET-BORIES
• Email: dupret-bories.agnes@iuct-oncopole.fr
• Phone: 05 31 15 53 08

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.