Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach

University of Milan

Status: Enrolling

Conditions: Leukoplakia, Oral

Treatments: Other: Wait and see approach; Procedure: Surgical excision of the lesion

Study type: Interventional

Funder types: Other

Identifiers

NCT04858100

LEUKO2020

Details and patient eligibility

About

This research protocol is comparing the effectiveness of surgical excision to the "wait and see" approach for the management of oral leukoplakia and erythroleukoplakia in prevention of oral squamous cell carcinoma onset.

Full description

Different treatments have been proposed for the management of oral leukoplakia (OL) in order to prevent oral squamous cell carcinoma onset. However, there is still no consensus on the most effective approach for the patients affected by such oral potentially malignant disorders. Surgery is often performed, but there is no randomized clinical trial which demonstrates its real effectiveness in preventing oral cancer onset.

A recent RCT compared surgical treatment with "wait and see approach" care in patients with nondysplastic OL, assuming that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic oral leukoplakias.

The purpose of this study is to evaluate effectiveness of surgical excision in treating OL and or reducing the onset of potential oral squamous cell carcinoma, with a follow-up of 5 years. This study will be the first RCT comparing the effectiveness of surgery to "wait and see approach" in the management of both dysplastic and nondysplastic oral leukoplakias.

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OL diagnosis should be confirmed by incisional diagnostic biopsy and subsequent histopathological analysis
• Subjects' age: 18 years or older
• Lesions' size: 3 cm maximum longitudinal size of the single lesion
• Lesions's location: oral areas with no surgical risk of damages to important anatomical structures such as nerves, salivary ducts and/or arteries.
• Ability to understand and to sign a written informed consent document

Exclusion criteria

• Previous oral cancer
• Head and neck radiotherapy
• Subjects under the age of 18
• Subjects affected by PVL (proliferative verrucous leukoplakia)
• High-risk of surgical damages to anatomical structures such as nerves, salivary ducts and/or arteries

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Surgery

Experimental group

Description:

Each patient will receive the surgical excision of the lesion and subsequent follow-up

Treatment:

Procedure: Surgical excision of the lesion

Wait and see

Active Comparator group

Description:

Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.

Treatment:

Other: Wait and see approach