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Trial record 49 of 251 for:    ASPIRIN AND low-dose aspirin

Adjuvant Low Dose Aspirin in Colorectal Cancer (ALASCCA)

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ClinicalTrials.gov Identifier: NCT02647099
Recruitment Status : Recruiting
First Posted : January 6, 2016
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
Uppsala University Hospital
Skane University Hospital
Information provided by (Responsible Party):
Anna Martling, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Acetylsalicylic acid Drug: Placebo Phase 3

Detailed Description:

ALASCCA is a randomized, parallel group, double blind, multicenter, placebo-controlled, biomarker-based study of adjuvant treatment with low dose aspirin in colorectal cancer.

Patients (adult male and female) with colorectal cancer clinical stage I-III with localized disease are considered for the study. Patients will be screened for inclusion at the time of surgery of the tumor (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.

A total of 3900 patients will be screened in order to include 408 patients with PIK3CA (Exon 9 and 20) mutated tumors in each treatment arm (Group A). With an estimated 20 % drop-out rate, 204 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 408 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 20 % drop-out rate, 204 patients will be randomized in each arm.

The randomization process is expected to take 24 months. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 816 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Placebo-controlled Study With ASA Treatment in Colorectal Cancer Patients With Mutations in the PI3K Signaling Pathway
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Aspirin
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
Drug: Acetylsalicylic acid
Other Name: ASA, aspirin

Placebo Comparator: Placebo
One tablet placebo orally once daily for three years
Drug: Placebo



Primary Outcome Measures :
  1. Time To Recurrence (TTR) [ Time Frame: 3 years ]
    local recurrence, distant metastases or death from same cancer


Secondary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: 3 years ]
  2. Overall survival (OS) [ Time Frame: 3 years ]
  3. Frequency and severity of adverse events (AE) [ Time Frame: 1 year and 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647099


Contacts
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Contact: Anna Martling, Professor 004651770000 ext 72802 anna.martling@ki.se
Contact: Sabine Sullow-Barin, Nurse 004651770000 sabine.sullow-barin@ki.se

Locations
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Sweden
Karolinska University Hsopital Recruiting
Stockholm, Sweden, 17176
Contact: Anna Martling, Prof    +468517772802    anna.martling@ki.se   
Sponsors and Collaborators
Anna Martling
Uppsala University Hospital
Skane University Hospital
Investigators
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Principal Investigator: Anna Martling, Professor Karolinska Institutet

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Responsible Party: Anna Martling, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02647099     History of Changes
Other Study ID Numbers: 921-2014-7074
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Anna Martling, Karolinska Institutet:
Aspirin
PI3K signaling pathway

Additional relevant MeSH terms:
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Aspirin
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics