PIK3CA mutated colon cancer
Conditions
Interventions
Trade Name: Aspirin
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number: 50-78-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
SAKK Swiss Group for Clinical Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Written informed consent according to ICH/GCP regulations before inclusion and prior to any trial-related investigations. 2 Histologically confirmed diagnosis of adenocarcinoma of the colon. 3 Stage II (pT3/T4 N0 cM0) or stage III (pTx pN+ cM0) colon cancer. 4 Availability of cancer tissue for central molecular testing. 5 Presence of predefined, activating PIK3CA mutation in exons 9 or 20 (centrally assessed, see section 17). 6 Complete resection of the primary tumor (R0) within 14 weeks maximum before registration. 7 WHO performance status 0-2 (see Appendix 3). 8 Age =18 years. 9 Adequate hematological values: hemoglobin = 80 g/L, platelets = 50 x 10^9/L. 10 Adequate hepatic function: total bilirubin =1.5xULN, AST =2.5xULN, ALT =2.5xULN, AP =2.5xULN. 11 Calculated creatinine clearance > 30 mL/min, according to the formula of Cockcroft-Gault (see Appendix 2). 12 Women with child-bearing potential are using effective contraception (see 9.6), are not pregnant or lactating and agree not to become pregnant during trial treatment. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1 Previous or concomitant malignancy within 3 years of registration, except for adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer. 2 Multiple adenocarcinomas of the colon. 3 Rectal cancer (defined as distance from anal verge to proximal/oral tumor edge =15 cm). 4 Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV (see Appendix 4), unstable angina pectoris, history of myocardial infarction) within three months prior to registration. 5 Systemic rheumatic diseases or degenerative disorders affecting the musculoskeletal system with a relevant risk of requiring treatment with NSAIDs in the future. 6 Comorbidities that require regular (i.e. more than 3x per month, any dose) intake of acetylsalicylic acid or other NSAIDs or COX-2 inhibitors. 7 Clinically relevant upper gastrointestinal bleeding within 12 months prior to registration. 8 Presence of any bleeding disorder that is an absolute contraindication to the use of aspirin. 9 General tendency to hypersensitivity and history of asthma triggered by salicylates of substances with a similar mechanism of action, and non-steroidal anti-inflammatory drugs in particular. 10 Any serious underlying medical condition, at the judgment of the investigator, which could impair the ability of the patient to participate in the trial (e.g. uncontrolled infection, active autoimmune disease, uncontrolled diabetes). 11 Concurrent treatment with other experimental drugs or treatment in an interventional clinical trial within 30 days prior to trial entry. Concomitant use of adjuvant chemotherapy for stage III and high risk stage II colon cancer according to international Treatment guidelines is allowed (chemotherapy regimens include intravenous 5-fluorouracil or oral capecitabine either alone or in combination with intravenous oxaliplatin). 12 Psychiatric disorder precluding understanding of trial information, giving informed consent or interfering with compliance for oral drug intake. 13 Any familial, sociological or geographical condition potentially hampering proper staging and compliance with the trial protocol. 14 Known or suspected hypersensitivity to any component of the trial drug or any agent given in association with this trial. 15 Known galactose-1-phosphate uridyl transferase deficiency, UDP galactose 4 epimerase deficiency, galactokinase deficiency, Fanconi-Bickel syndrome, congenital lactase deficiency or glucose-galactose malabsorption (due to lactose-containing placebo). 16 Any concomitant drugs contraindicated for use with the trial drug according to the approved product information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to demonstrate a statistically significant and clinically relevant disease free survival benefit in stage II and III PIK3CA mutated colon cancer patients taking daily adjuvant aspirin for 3 years.;Secondary Objective: Secondary endpoints of the trial are: ? Time to recurrence (TTR) ? Overall survival (OS) ? Cancer-specific survival (CSS) ? Adverse events (AEs);Primary end point(s): The primary endpoint of the trial is: ? Disease-free survival (DFS);Timepoint(s) of evaluation of this end point: DFS: time from surgery until one of the following events, whichever comes first: recurrence, second cancer, death due to any reason; evaluation by CT every 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints of the trial are: ? Time to recurrence (TTR) ? Overall survival (OS) ? Cancer-specific survival (CSS) ? Adverse events (AEs);Timepoint(s) of evaluation of this end point: TTR: time from surgery until recurrence or death due to colon cancer. OS: time from surgery until death from any cause. CSS: time from surgery until death due to colon cancer, whether due to the original tumor or to a second primary same cancer. AEs: continuously throughout study. AEs will be assessed according to NCI CTCAE v4.0. | — |
Countries
Belgium, Germany, Hungary, Switzerland
Contacts
Public ContactDr. Tobias Leidig
Crolll GmbH
Outcome results
None listed