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
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Acetylsalicylic acid Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||816 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Time To Recurrence (TTR) [ Time Frame: 3 years ]local recurrence, distant metastases or death from same cancer
- Disease free survival (DFS) [ Time Frame: 3 years ]
- Overall survival (OS) [ Time Frame: 3 years ]
- Frequency and severity of adverse events (AE) [ Time Frame: 1 year and 3 years ]
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
|Contact: Anna Martling, Professor||004651770000 ext email@example.com|
|Contact: Sabine Sullow-Barin, Nursefirstname.lastname@example.org|
|Karolinska University Hsopital||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Anna Martling, Prof +468517772802 email@example.com|
|Principal Investigator:||Anna Martling, Professor||Karolinska Institutet|