ALASCCA-A randomized double-blind placebo-controlled study with ASA treatment in colorectal cancer patients with mutations in the PI3K signaling pathway.
- Conditions
- Colon or rectal cancer tumor stage II-III, tumor with somatic alterationsin PIK3CA, PIK3R1 or PTEN.MedDRA version: 21.0Level: LLTClassification code 10010029Term: Colorectal cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004240-19-FI
- Lead Sponsor
- Karolinska University Hospital, Department of Molecular medicine and Surgery Karolinska Institutet, Gastrocentrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
- Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN
- Colon cancer stage II-III or rectal cancer tumor stage I-III
- Patient between18-80 years (including)
- Radical surgery according to surgeon and pathologist
- Karnofsky performance status =70%
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360
- 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). Postoperative treatment with low molecular weight heparin must be withdrawn before administration of study treatment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
Patients with regular administration of ASA, defined as >3 doses/week, will be included in the observation group. Other additional regular use of ASA must be withdrawn before randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method