Aspirin in Colorectal Cancer Liver Metastases (ASAC)
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| ClinicalTrials.gov Identifier: NCT03326791 |
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Recruitment Status :
Recruiting
First Posted : October 31, 2017
Last Update Posted : January 11, 2019
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Sponsor:
Oslo University Hospital
Collaborators:
Norwegian Cancer Society
The Research Council of Norway
KLINBEFORSK
Information provided by (Responsible Party):
Sheraz Yaqub, Oslo University Hospital
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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
MedlinePlus related topics:
Colorectal Cancer
Drug Information available for:
Aspirin
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention group
Acetylsalicylic acid 160 mg once daily until recurrent disease or a total period of 3 years.
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Drug: Acetylsalicylic acid
Trombyl 160 mg once daily
Other Names:
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Placebo Comparator: Control group
Placebo Oral Tablet once daily until recurrent disease or a total period of 3 years.
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Drug: Placebo Oral Tablet
Placebo one tablet daily |
Primary Outcome Measures :
- 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 :
- Time to recurrence (TTR) of disease after randomization [ Time Frame: 3 years ]Time to recurrence of liver metastases three years after start of treatment.
- Overall survival (OS) three years after treatment start [ Time Frame: 3 years ]OS at three years after initiation of treatment with ASA or Placebo
- 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.
- 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).
- 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.
- 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.
- 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
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| 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).
- In synchronous CRCLM and "Liver first" approach, the primary tumor must be resected within 6 weeks after the liver
- 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 >Stage 3b
- 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 | Recruiting |
| Aarhus, Denmark | |
| Contact: Frank V Mortensen, MD PhD +4578459006 franmort@rm.dk | |
| Rigshospitalet, Copenhagen | Recruiting |
| Copenhagen, Denmark | |
| Contact: Peter N Larsen, MD PhD +4527104290 | |
| Odense University Hospital | Recruiting |
| Odense, Denmark | |
| Contact: Claus Fristrup, MD PhD Claus.Wilki.Fristrup@rsyd.dk | |
| Norway | |
| Haukeland University Hospital | Recruiting |
| Bergen, Norway | |
| Contact: Jon-Helge Angelsen, MD PhD +4797520572 jon-helge.angelsen@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 | Recruiting |
| Stavanger, Norway | |
| Contact: Oddvar M Sandvik, MD PhD +4797468616 oddvar.mathias.sandik@sus.no | |
| University Hospital of North-Norway | Recruiting |
| Tromsø, Norway | |
| Contact: Kim Erlend Mortensen, MD PhD Kim.Erlend.Mortensen@unn.no | |
| St Olavs Hospital | Recruiting |
| Trondheim, Norway | |
| Contact: Jon Erik Grønbech, MD PhD +4790546058 jon.e.gronbech@ntnu.no | |
| Contact: Ingebjørg S Juel, MD PhD ingebjorg.soterud.juel@stolav.no | |
| Sweden | |
| Sahlgranska University Hospital | 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 | 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 | Recruiting |
| Umeå, Sweden | |
| Contact: Oskar Hemmingsson, MD PhD oskar.hemmingsson@umu.se | |
| Uppsala University Hospital | 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 11, 2019 |
| Last Verified: | January 2019 |
| 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:
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Acetylsalicylic acid Aspirin Trombyl Secondary prevention |
Additional relevant MeSH terms:
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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 |