Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers (OPTIFLAP)

Centre Francois Baclesse

Status and phase: Enrolling; Phase 3

Conditions: Oral Cavity Carcinoma; Flap; Radiotherapy, Adjuvant; Reconstruction Surgery

Treatments: Radiation: Post-operative radiotherapy with flap sparing; Radiation: Standard post-operative radiotherapy without flap sparing (current practice)

Study type: Interventional

Funder types: Other

Identifiers

NCT06798922

2024-A01764-43

Details and patient eligibility

About

Patients with oral cavity cancer treated by reconstructive surgery with a flap.

Patients will be treated in the study for :

• Experimental arm: Post-operative radiotherapy with flap sparing
• Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT)

Full description

Patients with oral cavity cancer treated by reconstructive surgery with a flap.

Patients will be treated in the study for :

• Experimental arm: Post-operative radiotherapy with flap sparing
• Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT) Our purpose is to demonstrate the feasibility of sparing surgical flaps from radiotherapy, in order to reduce toxicity while maintaining local disease control.

Enrollment: 348 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 2 patient groups

Standard arm

Active Comparator group

Description:

Standard IMRT or proton therapy practice, usual CTV definition

Treatment:

Radiation: Standard post-operative radiotherapy without flap sparing (current practice)

Experimental arm

Experimental group

Description:

IMRT or proton therapy with flap sparing

Treatment:

Radiation: Post-operative radiotherapy with flap sparing