A Phase 3 interventional study of Standard post-operative radiotherapy without flap sparing (current practice) and Post-operative radiotherapy with flap sparing in Oral Cavity Carcinoma, Flap and Radiotherapy, Adjuvant, sponsored by Centre Francois Baclesse. Recruiting at 30 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Centre Francois Baclesse · Phase 3, Interventional, and Treatment
Patients with oral cavity cancer treated by reconstructive surgery with a flap.
Patients will be treated in the study for :
Patients with oral cavity cancer treated by reconstructive surgery with a flap.
Patients will be treated in the study for :
446 studies on the registry are indexed under Mouth Neoplasms; 130 are open to participants now.
This study's planned enrollment of 348 is above the median of 60 across 313 interventional studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →Centre Francois Baclesse is the lead sponsor of 110 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 27, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard IMRT or proton therapy practice, usual CTV definition
Radiation: Standard post-operative radiotherapy without flap sparing (current practice)
IMRT or proton therapy with flap sparing
Radiation: Post-operative radiotherapy with flap sparing
Standard post-operative radiotherapy without flap sparing (current practice)
Post-operative radiotherapy with flap sparing
loco-regional control rate
To evaluate whether flap sparing yields non-inferior 2-year loco-regional control rate as flap-agnostic radiotherapy (as per standard routine practice) in completely resected oral cavity carcinomas undergoing postoperative radiotherapy
Time frame: 2 years after the end of postoperative radiotherapy
Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities
Rate of Ear-Nose-Throat (ENT) toxicities among cavity cancer patients with a flap, defined as the proportion of oral cavity cancer patients with at least two ENT toxicities grade ≥ 2 according to NCI-CTCAE v5.0
Time frame: within 12 months after postoperative radiotherapy
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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