- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02647099
Adjuvant Low Dose Aspirin in Colorectal Cancer (ALASCCA)
A Randomized Double-blind Placebo-controlled Study With ASA Treatment in Colorectal Cancer Patients With Mutations in the PI3K Signaling Pathway
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
A total of 3900 patients will be screened in order to include 300 patients with PIK3CA (Exon 9 and 20) mutated tumors in each treatment arm (Group A). With an estimated 10 % drop-out rate, 150 patients will be randomized in each arm. This also includes approximately 15 % of the patients that will be excluded due to tumor stage 1.
An additional 300 patients with mutations in other PI3K pathway genes PIK3CA (other than exon 9 and 20), PIK3R1 or PTEN will also be randomized in each arm and will be treated as a separate group in the analyses (Group B). With an estimated 10 % drop-out rate, 150 patients will be randomized in each arm.
Patients already treated with ASA at inclusion will be included in an observation group.
An interim analysis will be made on safety i.e incidence and type of serious bleeding complication grade > 1 after 12 months. An independent safety data monitoring committee will be responsible for evaluating and follow-up of the safety.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Aarhus, Denmark
- Aarhus University Hospital
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Randers, Denmark
- Randers Regional Hospital
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Viborg, Denmark
- Viborg Region Hospital
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Espoo, Finland
- Jorvi Hospital
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Helsinki, Finland
- Meilahti Tower Hospital
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Oslo, Norway
- Akershus University Hospital
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Stavanger, Norway
- Stavanger University Hospital
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Tromsø, Norway
- University Hospital of North Norway
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Trondheim, Norway
- St Olavs Hospital
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Falun, Sweden
- Falu Hospital
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Göteborg, Sweden
- Eastern Hospital
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Jönköping, Sweden
- Ryhov Hospital
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Karlskrona, Sweden
- Blekinge Hospital (Karlskrona-Karlshamn)
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Karlstad, Sweden
- Karlstad Central Hospital
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Linköping, Sweden
- Linköping University Hospital
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Luleå, Sweden
- Sunderby Hospital
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Malmö, Sweden
- Skane University Hospital
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Mora, Sweden
- Mora hospital
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Norrköping, Sweden
- Vrinnevi Hospital
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Skövde, Sweden
- Skaraborg Hospital
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Stockholm, Sweden
- Karolinska University Hospital
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Stockholm, Sweden
- Capio S:t Göran Hospital
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Stockholm, Sweden
- Ersta Hospital
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Stockholm, Sweden
- Danderyd Hospital
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Stockholm, Sweden
- South Hospital
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Sundsvall, Sweden
- Sundsvall Regional Hospital (Sundsvall-Härnösand)
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Trollhättan, Sweden
- Northern Älvsborg County Hospital
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Umeå, Sweden
- University Hospital of Umeå
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Uppsala, Sweden
- Uppsala University Hospital
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Västerås, Sweden
- Vasteras Central Hospital
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Ystad, Sweden
- Ystad Hospital
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Örebro, Sweden
- Örebro University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aspirin
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
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Other Names:
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Placebo Comparator: Placebo
One tablet placebo orally once daily for three years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time To Recurrence (TTR)
Time Frame: 3 years
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Defined as local recurrence, distant metastases or death from same cancer.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: 3 years
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3 years
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Disease free survival (DFS)
Time Frame: 3 years
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3 years
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Frequency and severity of adverse events (AE)
Time Frame: 1 year and 3 years
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1 year and 3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Martling, Professor, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 921-2014-7074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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