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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02647099
Other study ID # 921-2014-7074
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 7, 2016
Est. completion date August 2026

Study information

Verified date March 2024
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date August 2026
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Acetylsalicylic acid

Placebo


Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus
Denmark Randers Regional Hospital Randers
Denmark Viborg Region Hospital Viborg
Finland Jorvi Hospital Espoo
Finland Meilahti Tower Hospital Helsinki
Norway Akershus University Hospital Oslo
Norway Stavanger University Hospital Stavanger
Norway University Hospital of North Norway Tromsø
Norway St Olavs Hospital Trondheim
Sweden Falu Hospital Falun
Sweden Eastern Hospital Göteborg
Sweden Ryhov Hospital Jönköping
Sweden Blekinge Hospital (Karlskrona-Karlshamn) Karlskrona
Sweden Karlstad Central Hospital Karlstad
Sweden Linköping University Hospital Linköping
Sweden Sunderby Hospital Luleå
Sweden Skåne University Hospital Malmö
Sweden Mora Hospital Mora
Sweden Vrinnevi Hospital Norrköping
Sweden Örebro University Hospital Örebro
Sweden Skaraborg Hospital Skövde
Sweden Capio S:t Göran Hospital Stockholm
Sweden Danderyd Hospital Stockholm
Sweden Ersta Hospital Stockholm
Sweden Karolinska University Hospital Stockholm
Sweden South Hospital Stockholm
Sweden Sundsvall Regional Hospital (Sundsvall-Härnösand) Sundsvall
Sweden Northern Älvsborg County Hospital Trollhättan
Sweden University Hospital of Umeå Umeå
Sweden Uppsala University Hospital Uppsala
Sweden Västerås Central Hospital Västerås
Sweden Ystad Hospital Ystad

Sponsors (3)

Lead Sponsor Collaborator
Anna Martling Skane University Hospital, Uppsala University Hospital

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time To Recurrence (TTR) Defined as local recurrence, distant metastases or death from same cancer. 3 years
Secondary Disease free survival (DFS) 3 years
Secondary Overall survival (OS) 3 years
Secondary Frequency and severity of adverse events (AE) 1 year and 3 years
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