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

Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Leukoplakia, Oral
• Intervention / Treatment: Procedure: Surgical excision of the lesion; Other: Wait and see approach

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 Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giovanni Lodi, PhD, DMD; Phone Number: 00390250319021; Email: giovanni.lodi@unimi.it

Study Locations

• Italy
  • Milan, Italy, 20142
    • Recruiting
    • University of Milan
    • Contact: Giovanni Lodi; Phone Number: 003950319021; Email: giovanni.lodi@unimi.it
  • TO
    • Turin, TO, Italy, 10126
      • Recruiting
      • Università degli Studi di Torino Dental School
      • Contact: Paolo Arduino, DDS; Email: paologiacomo.arduino@unito.it
      • Contact: Paolo Arduino, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery; Each patient will receive the surgical excision of the lesion and subsequent follow-up	Procedure: Surgical excision of the lesion; The surgical removal of the lesion, performed within 3 months from the final diagnosis, will follow these steps: local anesthesia; excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having at least 2 mm-free margins; silk or resorbable suture for wound closure The patient will be recall after 14 days for assessing the wound healing and after 30 days for providing and explaining him the histopahtological exam. The patient will receive a 3-6 month follow-up according to the clinical and histopathological case.
Active Comparator: Wait and see; Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.	Other: Wait and see approach; The patient will receive a 3-6 month follow-up according to the clinical and histopathological case, with periodical incisional biopsy every 4 control visit. In case of OSCC onset during the first 3 months after the final diagnosis, the patient will be excluded since the oral cancer occurence will be considered as a misdiagnosis, more than a "true" malignat progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral cancer incidence	Number of patients who will develop oral squamous cell carcinoma	every 3 or 6 months (according to the clinical case) up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to malignant transformation from diagnosis	Period of time required to develop malignancy	every 3 or 6 months (according to clinical case) up to 5 years
Quality of life after surgical excision	To evaluate the quality of life of patients affected by leukoplakia and treated with surgical excision, via Functional Intraoral Glasgow Scale (FIGS) questionnaire. FIGS is a simple point scale used to assess a patient's ability to speak, chew and swallow. Each of these functions is scored independently on a scale of 1-5, five being no disability and one meaning the patient has an inability to speak, chew, or swallow.	month 1 and month 6

Collaborators and Investigators

• Sponsor: University of Milan
• Investigators: Principal Investigator: Giovanni Lodi, PhD, DMD, University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cancer prevention; Oral Potentially Malignant Disorder; Oral carcinoma; Oral medicine
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Precancerous Conditions; Mouth Neoplasms; Leukoplakia; Leukoplakia, Oral
• Other Study ID Numbers: LEUKO2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No