Evaluating Treatment Strategies for p53 Mutant Oral Epithelial Dysplasia and SCC Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 636
- 试验地点
- 2
- 主要终点
- Progression to severe/CIS dysplasia or SCC
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 or over
- •No history of head and neck radiation
- •p53-abnormal IHC patterns (surrogate marker for TP53 mutation)
- •Biopsy-confirmed mild/moderate dysplasia
- •Biopsy-confirmed severe dysplasia or CIS
- •T1 SCC with depth of Invasion (DOI) <4mm
- •Clinically and radiologically node-negative (confirmed by contrast-enhanced CT)
排除标准
- •Immunocompromised status
- •Lesions greater than 3 cm
- •Presence of Proliferative Verrucous Leukoplakia
- •Had prior treatment for oral premalignant lesions
- •Presence of invasive SCC on initial biopsy
- •Positive nodes on contrast-enhanced CT
- •DOI >= 4mm
研究组 & 干预措施
Cohort 1: p53 mutant mild/moderate dysplasia observational group
Observation only
Cohort 1: p53 mutant mild/moderate dysplasia excision group
Clear margin excision of the lesion under local anesthetic, with re-excision for p53-positive margins
干预措施: Cohort 1 Intervention group (Procedure)
Cohort 2: p53 mutant Severe/CIS dysplasia clear severe/CIS margin group
Clear margin excision of the lesion under local anesthetic, with re-excision until severe/CIS margins are clear
干预措施: Cohort 2 severe/CIS margins clear (Procedure)
Cohort 2: p53 mutant Severe/CIS dysplasia negative p53 and severe/CIS margin group
Excision of the lesion ensuring final negative p53 and severe/CIS margins
干预措施: Cohort 2 p53 and severe/CIS margins clear (Procedure)
Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and follow up group
Excision of primary lesion and close follow up with salvage neck dissection if development of nodal disease
干预措施: Cohort 3 Excision and Close follow up (Procedure)
Cohort 3: p53 mutant T1 SCC (DOI <4mm) excision and END group
Excision of primary lesion and immediate elective neck dissection (END)
干预措施: Cohort 3 Excision and END (Procedure)
结局指标
主要结局
Progression to severe/CIS dysplasia or SCC
时间窗: 4 years
Whether diagnosis progressed from mild/moderate OED to severe/CIS dysplasia or SCC.
Progression to invasive SCC
时间窗: 4 years
Whether diagnosis progressed from severe/CIS dysplasia to invasive SCC.
Disease free survival
时间窗: 4 years
If survival is achieved disease free following treatment.
次要结局
- Overall survival(4 years)
- Time to progression(4 years)
- p16 status(4 years)
研究者
Eitan Prisman
Principal Investigator
University of British Columbia