ClinicalTrials.gov
ClinicalTrials.gov Menu

Aspirin in Colorectal Cancer Liver Metastases (ASAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03326791
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
Norwegian Cancer Society
The Research Council of Norway
KLINBEFORSK
Information provided by (Responsible Party):
Sheraz Yaqub, Oslo University Hospital

Brief Summary:

The ASAC trial is a Scandinavian, multi-center, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose acetylsalicylic acid (ASA) can improve disease free survival in patients treated with resection for colorectal cancer liver metastases (CRCLM).

Several studies have shown beneficial effect of ASA on primary prevention of CRC and the investigators group and others have shown a potential association of ASA also taken after the diagnosis on CRC survival in registry-based studies (secondary prevention). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo for a period of 3 years or till disease recurrence. The patients will be treated and followed up according to standard of care and the National Guidelines.

The ASAC trial will be the first clinical interventional trial to assess the beneficial role of ASA in recurrence of CRC liver metastases and survival. ASA is an inexpensive, well tolerated, and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRC liver metastases if the study shows a beneficial effect. This trial will also investigate the effect of ASA as adjuvant treatment on Health-related Quality of Life and the cost-effectiveness.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastases Colorectal Cancer Liver Metastases Drug: Acetylsalicylic acid Drug: Placebo Oral Tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-centre, double-blinded, randomized, placebo-controlled clinical intervention trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Eligible patients will be allocated in a 1:1 ratio using a computer randomization procedure stratified by centre. The randomization will be blocked within each stratum.
Primary Purpose: Prevention
Official Title: Acetylsalicylic Acid as Secondary Prevention in Colorectal Cancer
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Intervention group
Acetylsalicylic acid 160 mg once daily until recurrent disease or a total period of 3 years.
Drug: Acetylsalicylic acid
Trombyl 160 mg once daily
Other Names:
  • Trombyl
  • Aspirin

Placebo Comparator: Control group
Placebo Oral Tablet once daily until recurrent disease or a total period of 3 years.
Drug: Placebo Oral Tablet
Placebo one tablet daily




Primary Outcome Measures :
  1. Disease Free Survival (DFS) after three years treatment [ Time Frame: 3 years ]
    DFS three years after initiation of treatment with ASA or Placebo after resection of liver metastases.


Secondary Outcome Measures :
  1. Time to recurrence (TTR) of disease after randomization [ Time Frame: 3 years ]
    Time to recurrence of liver metastases three years after start of treatment.

  2. Overall survival (OS) three years after treatment start [ Time Frame: 3 years ]
    OS at three years after initiation of treatment with ASA or Placebo

  3. Health-related Quality of Life with 36-item Short Form Health Survey (SF-36) [ Time Frame: 3 years ]
    SF-36 has been proven useful in monitoring population health, estimating the burdens of different diseases, monitoring outcome in clinical practice, and evaluating medical treatment effects. Health-related Quality of Life (HR-QoL) will be assessed with SF-36.

  4. Health-related Quality of Life with EuroQoL 5 Dimensions (EQ-5D) [ Time Frame: 3 years ]
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This will be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions will be presented as a health profile. Health-related Quality of Life (HR-QoL) will be assessed with EuroQoL 5 Dimensions (EQ-5D).

  5. ASA in CRC and Cost-Effectiveness Analyses I [ Time Frame: 3 years ]
    Changes in HR-QoL will be used in calculation of the quality-adjusted life-year (QALY), a key outcome used in economic evaluations to compare treatments.

  6. ASA in CRC and Cost-Effectiveness Analyses II [ Time Frame: 3 years ]
    Cost-effectiveness measured from a health care perspective by assessing the use of Health care provider in primary and specialized medicine.

  7. ASA in CRC and Cost-Effectiveness Analyses III [ Time Frame: 3 years ]
    Cost-effectiveness measured from a societal perspective by assessing records in Statistics Norway (SSB).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • First time CRCLM (synchronous or metachronous).
  • Recurrence of CRCLM (not previously included in this trial).
  • Macroscopic (surgical) free resection margins (R0 or R1 resection).
  • Must be ambulatory with a performance status Eastern Cooperative Oncology Group (ECOG) 0-2.
  • Must be at least 18 years of age.
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization - Good Clinical Practice (ICH GCP), and national/local regulations.

Exclusion Criteria:

  • Concomitant use of ASA or other anticoagulants or platelet inhibitors such as warfarin or clopidogrel.
  • Ongoing regular use of corticosteroids or NSAIDs.
  • Inherited or acquired coagulopathy (haemophilia).
  • Blood platelets (thrombocytes) < 100 x 10^9/L.
  • Severe heart failure (classified as New York Heart Association (NYHA) class >III)
  • Severe kidney failure.
  • CRCLM previously treated with radiofrequency or microwave ablation technique
  • Pregnancy or breastfeeding. For women in childbearing age there will be pregnancy test at monthly intervals (urine human chorionic gonadotropin (HCG) pregnancy tests (for home testing) will be given to the patients for monthly tests and the patient will self-report the results at each control). Furthermore, highly effective contraceptives will be required.
  • Childbearing potential without proper contraceptive measures such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device to avoid pregnancy for the entire study period.
  • Liver cirrhosis with a Child-Pugh score >B7.
  • Alcoholism.
  • Contraindication listed on the Summary of Product Characteristics (SmPC) of Trombyl: Hypersensitivity/allergies to ASA, Thrombocytopenia, Previous severe gastrointestinal haemorrhage/peptic ulcer due to ASA/NSAID, Active peptic ulcer, Haemophilia, Liver cirrhosis, Severe congestive heart failure.
  • Need to use concomitant medications contraindicated according to SmPC of Trombyl.

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): NCT03326791


Contacts
Contact: Anja Kokvoll, Nurse +4747908528 anjkok@ous-hf.no
Contact: Victoria Bringsjord, Nurse +4747908528 vicbri@ous-hf.no

Locations
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark
Contact: Frank V Mortensen, MD PhD    +4578459006    franmort@rm.dk   
Rigshospitalet, Copenhagen Not yet recruiting
Copenhagen, Denmark
Contact: Peter N Larsen, MD PhD    +4527104290      
Odense University Hospital Not yet recruiting
Odense, Denmark
Contact: Claus Fristrup, MD PhD       Claus.Wilki.Fristrup@rsyd.dk   
Norway
Haukeland University Hospital Not yet recruiting
Bergen, Norway
Contact: Arild Horn, MD PhD    +4792034290    arild.horn@helse-bergen.no   
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Sheraz Yaqub, MD PhD    +4790953996    shya@ous-hf.no   
Contact: Bjørn A Bjørnbeth, MD PhD    +4747287853    bbjoer@ous-hf.no   
Stavanger University Hospital Not yet recruiting
Stavanger, Norway
Contact: Jon Arne Søreide, MD PhD    +4790531770    jonarne.soreide@mac.com   
University Hospital of North-Norway Not yet recruiting
Tromsø, Norway
Contact: Kim Erlend Mortensen, MD PhD       Kim.Erlend.Mortensen@unn.no   
St Olavs Hospital Not yet recruiting
Trondheim, Norway
Contact: Jon Erik Grønbech, MD PhD    +4790546058    jon.e.gronbech@ntnu.no   
Sweden
Sahlgranska University Hospital Not yet recruiting
Gothenburg, Sweden
Contact: Magnus Rizell, MD PhD    +46705259301    magnus.rizell@surgery.gu.se   
Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Per Sandström, MD PhD       per.sandstrom@liu.se   
Skåne University Hospital Lund Not yet recruiting
Lund, Sweden
Contact: Gert Lindell, MD PhD    +4646176288    gert.lindell@med.lu.se   
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Ernesto Sparelid, MD PhD       ernesto.sparrelid@ki.se   
University Hospital of Umeå Not yet recruiting
Umeå, Sweden
Contact: Oskar Hemmingsson, MD PhD       oskar.hemmingsson@umu.se   
Uppsala University Hospital Not yet recruiting
Uppsala, Sweden
Contact: Bengt Isaksson, MD PhD    +46736994477      
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
The Research Council of Norway
KLINBEFORSK
Investigators
Principal Investigator: Bjørn A Bjørnbeth, MD PhD Oslo University Hospital
Principal Investigator: Kjetil Taskèn, MD PhD University of Oslo
Principal Investigator: Sheraz Yaqub, MD PhD Oslo University Hospital

Additional Information:
Responsible Party: Sheraz Yaqub, MD PhD, Coordinating Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03326791     History of Changes
Other Study ID Numbers: 2014/2217
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sheraz Yaqub, Oslo University Hospital:
Acetylsalicylic acid
Aspirin
Trombyl
Secondary prevention

Additional relevant MeSH terms:
Aspirin
Colorectal Neoplasms
Colonic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver 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