NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 13
- 主要终点
- Disease free survival
研究概览
简要总结
This study investigates if circulating tumor DNA can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (SCCA) after curative chemoradiotherapy thereby increasing the potential for cure. This will be done by comparing the standard follow-up program with ctDNA guided imaging follow-up. Secondly, the aim is to establish early interventions against late morbidities.
详细描述
Squamous cell carcinoma of the anus (SCCA) is a rare disease with less than 200 new cases in Denmark and Sweden each year and approximately 100 new cases in Norway and Finland but with increasing incidence. Primary treatment is chemo-radiotherapy (CRT) comprising high dose IMRT based radiation therapy with combination chemotherapy of 5-FU and Cisplatin. Overall treatment response is good in small tumors, but less pronounced for high-risk tumors.
In absence of complete pathological response after CRT or local recurrence, patients are evaluated for. salvage surgery. The importance of R0 resection on overall survival has been described in several studies. It is suggested that early detection of treatment failure and recurrences increases the chance of possible curative surgery (R0-resection) and thereby overall survival.
A follow-up program has 3 purposes
- To detect lack of complete response to primary treatment
- Early detection of local or distant recurrences
- Describing and managing late morbidity
Purpose:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Patients with SCCA eligible for definitive (chemo)radiotherapy
- •≥ 18 of years
- •Written and oral consent
排除标准
- •Conditions that will contraindicate blood samples
- •Conditions that will contraindicate a PET-CT scan.
- •Potential lack of compliance to standard FU program and study participation.
研究组 & 干预措施
ARM B: HPV positive ctDNA guided imaging in follow-up
The national follow-up program + ctDNA guided additional imaging + collection of blood samples for retrospective translational research
干预措施: AMR B: HPV positive ctDNA guided imaging in follow-up (Diagnostic Test)
ARM O: HPV negative observational arm
Patients with HPV negative disease will be included in an observational arm (ARM O)
ARM O: The national follow-up program + collection of blood samples for retrospective translational research
ARM A: HPV positive standard of care follow-up
The national follow-up program + collection of blood samples for retrospective translational research
结局指标
主要结局
Disease free survival
时间窗: after 2 years
Disease free survival 2 years from end of therapy
次要结局
- ctDNA assays for HPV negative cases(5 years)
- Health related quality of life(after 2 and 5 years)
- Overall survival(5 years)
- The rate of distant failures(after 5 years)
- Time between ctDNA detected and CT verified recurrences(after 5 years)
- Rate of succesful salvage surgery(after 5 years)
- Pattern of failure(after 5 years)
- Disease free survival at 5 years follow-up(after 5 years)
- Explorative analysis of total circulating free DNA (cfDNA)(5 years)
- Acute toxicity(after 2 and 5 years)
- Late toxicity(after 2 and 5 years)
研究者
Karen-Lise Garm Spindler
Professor, Dr. Med.
Aarhus University Hospital