Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Milan
- Enrollment
- 310
- Locations
- 2
- Primary Endpoint
- Oral cancer incidence
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Surgery
Each patient will receive the surgical excision of the lesion and subsequent follow-up
Intervention: Surgical excision of the lesion (Procedure)
Wait and see
Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.
Intervention: Wait and see approach (Other)
Outcomes
Primary Outcomes
Oral cancer incidence
Time Frame: every 3 or 6 months (according to the clinical case) up to 5 years
Number of patients who will develop oral squamous cell carcinoma
Secondary Outcomes
- Time to malignant transformation from diagnosis(every 3 or 6 months (according to clinical case) up to 5 years)
- Quality of life after surgical excision(month 1 and month 6)
Investigators
Giovanni Lodi
Associate Professor
University of Milan