Tailored Adjuvant Therapy in POLE-mutated and p53-wildtype Early Stage Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Pelvic recurrence
研究概览
简要总结
Endometrial cancer(EC) is the 4th most common cancer in women globally. Clinicians struggle to determine 'the best' treatment for endometrial cancers as they are very hard to tell apart under the microscope. Our BC team developed and validated a low-cost practical tool that can reliably distinguish ECs by molecular features. Molecular classification can inform women about the likelihood of their disease coming back as well as which treatments might work best for them or are not needed. Investigators are studying how this classifier can identify women at very low risk of disease recurrence in order to spare them toxic therapies.
详细描述
Purpose:
This proposal will for the first time test the clinical utility of ProMisE in a pan-Canadian setting. Through molecular classification, Investigators are closer to providing consistent treatment to women with EC reducing disparities in care as might be observed according to geography/access to care, and/or racial differences. As the primary focus for this trial investigators will focus on identifying women investigators believe may be overtreated, working to avoid giving toxic therapies with consequential side effects of treatment as many women with EC may be cured by surgery alone. However, by performing molecular classification for all new ECs enrolled investigators will also be able to identify women who are at increased risk of recurrence or death from their disease based on molecular features and direct them to molecular-subtype-specific clinical trials. This will, investigators believe, reduce undertreatment (not identifying and treating women at high risk for recurrence) and will help select the best treatment according to an individuals tumor biology. In summary, the research proposed will assess the feasibility and impact of ProMisE-directed care within a rigorous clinical setting - fulfilling the last step in bringing molecular classification-driven care to women across the country with EC and ultimately improving outcomes for women with this disease.
Hypothesis:
There is a subgroup of early stage endometrial carcinomas that are at very low risk of pelvic recurrence and can be identified through molecular classification providing an opportunity to withhold or deescalate adjuvant therapy.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed endometrial carcinoma, with one of the following combinations of FIGO stage, grade, and LVI: Stage IA (not confined to polyp), grade 3 (with or without LVI), pN0 Stage IB, grade 1, 2 pNx/N0 with or without LVI Stage IB, grade 3 without LVI pN0 Stage II (microscopic), grade 1 or 2, pN0 and without substantial LVI Surgery consisting of hysterectomy (total abdominal, laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards (sentinel or full lymphadenectomy). Pelvic LN assessment is required for grade 3 or stage II cancers. Para-aortic lymphadenectomy is not mandated.
- •Age ≥18 years
- •Eastern Cooperative Group (ECOG) performance status 0, 1 or
- •Ability to understand and willing to sign a written informed consent document.
排除标准
- •Prior chemotherapy for endometrial cancer or previous pelvic radiation.
- •History of another invasive malignancy, except for non-melanoma skin cancers or tumors curatively treated with no evidence of disease for ≥ 5 years
- •Inability to be registered and receive treatment within 12 weeks of hysterectomy .
- •Abnormal p53 (p53abn) and/or mismatch repair deficiency (MMRd) on immunohistochemistry without pathogenic POLE mutation.
- •MELF (microcystic, elongated and fragmented (MELF)) pattern of invasion is excluded within p53wt/NSMP tumors, not POLEmut
结局指标
主要结局
Pelvic recurrence
时间窗: every 6 months for the first 3 years
recurrent disease in the pelvis (including the vagina)
次要结局
- Recurrence free survival(every 6 months for the first 3 years)
- Overall survival(every 6 months for the first 3 years)
- Sites of relapse(every 6 months for the first 3 years)
- Patient Decisional Conflict Scale(through study completion, an average of 3 years)
- Variation in treatment(through study completion, an average of 3 years)
研究者
Jessica McAlpine
Gynaecologic Oncologist
British Columbia Cancer Agency