Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

Launched by CENTRE FRANCOIS BACLESSE · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to treating patients with oral cavity cancer who have undergone reconstructive surgery using a technique called "flap sparing." In this study, some participants will receive a specific type of radiation therapy after their surgery that aims to protect the reconstructed area (the flap), while others will receive the standard radiation therapy currently used, which does not focus on preserving the flap. The goal is to see if this new method can improve outcomes for patients.

To be eligible for this trial, participants need to be at least 18 years old and have had surgery for oral cavity cancer with a flap reconstruction. They should also be in fairly good health, meaning they can perform daily activities without much difficulty. The study is not yet recruiting participants, but once it starts, those who join can expect to receive either the experimental treatment or the standard care, along with monitoring and support throughout the process. It's important to note that certain patients, such as those with a history of head or neck radiation, or those who are pregnant, will not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient aged 18 years or older
• • Performance Status 0-2
• • Patient with oral cavity cancer (soft tissue or soft tissue-bone flap), treated by reconstructive surgery with a flap. Oropharynx cancer whose flap extends significantly into the oral cavity may be included in the study
• • Quality of resection with margins \> 1 mm
• • Patient candidate to post-operative radiotherapy (Intensity-Modulated Radiation Therapy (IMRT) or proton therapy)
• • Concomitant chemotherapy is allowed (stratification parameter)
• • Patient must have signed a written informed consent form prior to any trial specific procedures
• • Patient affiliated to the social security system
• Exclusion Criteria:
• • Local flap (small size limiting IMRT modulation potential)
• • History of radiotherapy of head and neck area
• • Metastatic disease
• • History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
• • Simultaneous participation in another clinical study may compromise the conduct of this study.
• • Pregnant or lactating women
• • Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
• • Patient deprived of freedom or under guardianship