Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors

Condition(s) studied

Investigational drug(s) / intervention(s)

Cohort 1 Intervention group: Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins.

Cohort 2 severe/CIS margins clear: Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear

Cohort 2 p53 and severe/CIS margins clear: Excision of the lesion ensuring final negative p53 and severe/CIS margins

Cohort 3 Excision and END: Excision of primary lesion and immediate elective neck dissection

Cohort 3 Excision and Close follow up: Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease

Study summary

The goal of this clinical trial is to optimize treatment strategies for patients with p53-mutant oral epithelial dysplasia (OED) and early-stage oral squamous cell carcinoma (OSCC). The main question it aims to answer is what the most optimal treatment is at each diagnostic stage. It is hypothesized that lesions with p53-abnormal low-grade dysplasia (LGD) without surgical intervention will progress to high-grade dysplasia (HGD) or SCC in 4 years. It is also predicted that a clear p53 and severe/CIS excision margins in patients with p53-abnormal HGD will reduce the progression to invasive SCC, compared to clear severe/CIS margins, within 4 years. Finally, it is thought that patients with p53-abnormal cT1N0 and DOI\<4mm receiving an END will have improved disease free and overall survival. This research will elucidate whether or not these hypotheses are correct.

Participants in each diagnostic cohort will be assigned to one of two different treatment options, listed below:

Cohort 1:

A) No intervention, observation only B) Surgical excision with clear margins

Cohort 2:

A) Surgical excision with clear severe/CIS margins B) Surgical excision with clear severe/CIS and p53 margins

Cohort 3:

A) Surgical excision and elective neck dissection (END) B) Surgical excision and close follow-up, only salvage ND if development of nodal disease

Eligibility

Primary outcome measure(s)

• Progression of Disease — 4 years
  Study 1: Whether diagnosis progressed from low-grade dysplasia (mild/moderate OED) to high-grade (severe/CIS) dysplasia or OSCC. Study 2: Whether diagnosis progressed from high-grade (severe/CIS) dysplasia to OSCC.
• Time of Disease Progression — 4 years
  Study 1: Time for disease to progress from low-grade dysplasia (mild/moderate OED) to high-grade (severe/CIS) dysplasia or OSCC. Study 2: Time for disease to progress from high-grade (severe/CIS) dysplasia to OSCC.
• Recurrence of Disease — Study 1 and 2: 4 years, Study 3: 3 years
  Study 1: Whether recurrence of low-grade dysplasia is present. Study 2: Whether recurrence of high-grade dysplasia is present. Study 3: Whether recurrence of OSCC is present, and if recurrence pattern is local recurrence or nodal metastasis. All: Time for disease to recur.
• Disease-free Survival — 3 years
  Study 3: If survival is achieved disease-free following treatment.

Trial sites (1)

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