A Randomized Double-blind Placebo-controlled Study With ASA Treatment in Colorectal Cancer Patients With Mutations in the PI3K Signaling Pathway
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 626
- 试验地点
- 32
- 主要终点
- Time To Recurrence (TTR)
研究概览
简要总结
ALASCCA is a randomized, parallel group, double blind, multicenter, placebo-controlled, biomarker-based study of adjuvant treatment with low dose aspirin in patients with colorectal cancer. Hypothesis is that patients diagnosed with colorectal cancer and somatic mutations in PI3K pathway can significantly improve survival if treated with low dose aspirin.
详细描述
Patients with colorectal cancer clinical stage I-III will be screened for inclusion at the time of tumor surgery (at time of routine patient visit before elective surgery or postoperatively within 12 weeks in case of emergency procedure or if screening was missed preoperatively). After inclusion and when surgery is performed, patients with PIK3 mutations and stage II and III tumors will be randomized to receive 160 mg aspirin or placebo orally.
Last date for randomization and start of treatment is 12 weeks postoperatively. The treatment can be administered alone or in combination with adjuvant chemotherapy. The choice of any adjuvant chemotherapy is made by the Investigator and should follow the guidelines in the National Care Program. The treatment will be administered for 3 years. There will be a follow-up period for two years. Outside the trial, the patient will be treated according to standard care at the site.
A phone contact will be made 3 months after the randomization visit and thereafter every 6th month. The patients will also visit the site 6 months after randomization and thereafter every 6th month i.e. the patients will be in contact with the site every 3rd month. There will also be a visit/phone contact at the end of the follow-up period.
The primary objective is to determine whether adjuvant treatment with 160mg ASA once daily for 3 years can improve time to recurrence in participants with colorectal cancer with somatic alternations in the PI3K singling pathway.
UPDATE: New dimensional analysis and power calculation, 19th October 2020:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN
- •Colon or rectal cancer tumor stage II-III
- •Radical surgery according to surgeon and pathologist
- •Karnofsky performance status ≥60%
- •Platelets ≥ 100 x 109 / L
- •Clean Colonoscopy or Computed Tomography (CT) colon within 3 months preoperatively or postoperatively but before randomization
- •Patient able to swallow tablets
- •Patient able to understand and sign written informed consent
排除标准
- •Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
- •Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •Distant metastases
- •Other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening
- •Known bleeding diathesis (such as hemophilia)
- •Concomitant antiplatelet therapy (eg clopidrogrel or ticlopidine) or anticoagulant therapy (warfarin or low molecular weight heparin). Post-operative treatment with low molecular weight heparin must be withdrawn before administration of study treatment
- •Active gastritis or peptic ulcer, or significant surgical post-op bleeding, within the previous three months assessed at screening and randomization
- •Ongoing regular use of corticosteroids, Nonsteroidal Anti-Inflammatory Drug (NSAID)
- •Uncontrolled hypertension according to Investigator's judgment
- •Clinically significant liver impairment according to Investigators judgment
- •Existing renal failure according to Investigator's judgment. Renal failure with decreased creatinine clearance <60 should lead to consultation with a nephrologist.
- •Significant medical illness that would interfere with study participation
- •Pregnancy or breastfeeding females
- •Known allergy to NSAIDs or ASA
- •Current participation in another clinical trial that will be in conflict with the present study
- •Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study
研究组 & 干预措施
Aspirin
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
干预措施: Acetylsalicylic acid (Drug)
Placebo
One tablet placebo orally once daily for three years
干预措施: Placebo (Drug)
结局指标
主要结局
Time To Recurrence (TTR)
时间窗: 3 years
Number of participants with local recurrence, distant metastases or death from same cancer within 3 years from randomization
次要结局
- Disease Free Survival (DFS)(3 years)
- Overall Survival (OS)(5 years)
- Frequency and Severity of Adverse Events (AE)(1 year and 3 years)
研究者
Anna Martling
Professor
Karolinska Institutet