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A Randomized, Phase II, Double-blind, Placebo-controlled, Multicenter, 2x2 Factorial Design Biomarker Tertiary Prevention Trial of Low-dose Aspirin and Metformin in Stage I-III Colorectal Cancer Patients. The ASAMET Trial

Studio Clinico

Patologia: Tumori del colon retto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: 

Fase di studio: II Randomizzato

Richiesta mandatoria di tessuto: 

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- Patients aged > 18 and ≤ 80 years.
- Patients with completely resected stage I, II, or III primary colorectal cancer within 24 months prior to randomization, regardless of (neo-)adjuvant chemotherapy. Patients with pT1 CRC treated with endoscopic polypectomy.
- Adjuvant chemotherapy and (neo-)adjuvant radiotherapy terminated at least 3 months before randomization.
- ECOG performance status ≤ 1.
- Satisfactory hematological and biochemical functions:
    - Platelets ≥ 100 x 10^9/L
    - Creatinine clearance estimated with the Cockcroft - Gault formula ≥ 60 mL/min. Patients with Gault formula ≥ 45-59 ≤ ml/min are eligible but they will receive a single (evening) tablet of MET, 850 mg.
    - AST and ALT ≤ 2.5 times ULN.
- Females of childbearing potential/males with partners of childbearing potential participating in the study are to use effective methods of birth control during study participation. Female participants must provide a pregnancy test, according to local/national guidelines.
- Able to understand and sign an informed consent (or have a legal representative who is able and willing to do so).

Criteri di esclusione: 

- Patients who are not able to undergo colonoscopy.
- Patients who are allergic or intolerant to ibuprofen or naproxen,or who have MET-, or ASA-, or salicylate intolerance or more generalized drug intolerance to non-steroidal anti-inflammatory drugs (NSAIDs).
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing or participating in the study and/or comply with study procedures.
- Chronic treatment with ASA or other NSAIDs or MET or patients who are on current long term treatment (≥ 4 consecutive weeks) with ASA, NSAID or COX -2 inhibitors or MET.
- Diabetic patients on drug treatment are excluded.
- Anticoagulant therapy (dicumarol, heparin, fondaparinux, apixaban, dabigatran etexilate, rivaroxaban) or active current treatment with antiplatelet agents (e.g. off-study ASA, clopidogrel, prasugrel, ticagrelor, or ticlopidine).
- Any other invasive malignancies (with the exclusion of basal cell carcinoma or cutaneous squamous cell carcinoma) diagnosed during the last 5 years before randomization. Past history of any other invasive CRC than the one the patient is currently being treated for
- Alcohol or drug abuse.
- Prior history of gastro-intestinal bleeding or hemorrhagic diathesis (e.g. hemophilia).
- Erosive-ulcerative lesions in the gastrointestinal tract.
- History of erosive GERD or active erosive GERD on gastroscopy.
- Concomitant corticosteroid treatment.
- Known deficiency of glucose-6-phosphate dehydrogenase (G6PD).
- Treatment with another investigational drug < 28 days prior to study entry.
- Concurrent participation in a clinical trial with the same endpoints.
- History of hemorrhagic stroke.
- Lynch Syndrome (HNPCC).
- Crohn's disease (CD) and Ulcerative Colitis (UC).
- Pregnant or lactating females.
- History of lactic acidosis.
- Liver dysfunction including chronic active hepatitis and cirrhosis not compensated.
- History of vitamin B12 deficiency or megaloblastic anemia.
- Uncontrolled coronary syndrome or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification).
- Inability or unwillingness to swallow tablets.

Trattamento sperimentale: 

Arm B: placebo Aspirin (1 tablet daily) + active Metformin (850 mg, 1 tablet BID)
Arm C: active Aspirin (100 mg, 1 tablet daily) + placebo Metformin (1 tablet BID)
Arm D: active Asprin (100 mg, 1 tablet daily) + active Metformin (850 mg, 1 tablet BID)

Trattamento di controllo: 

ARM A: placebo Aspirin (1 tablet daily) + placebo Metformin (1 tablet BID)

Obiettivi primari dello studio: 

NFκB [Time Frame: 1 year]
It will be measured the change, defined as the difference between post- and pre-treatment levels, in NFκB expression in normal colonic tissue. The NFκB transcription factor family is composed of the p65, RelB, c-Rel, p105, andt p100 subunits, and activation of the NFκB pathway is defined by the nuclear translocation of the p65 subunit. Therefore, cytoplasmic and nuclear localization of p65 will be immunohistochemically assessed as an indicator of NFκB activity. The analysis of expression will be performed by semi quantitative assessment: NFκB expression will be measured primarily as the percentage of positive nuclear areas for NFkB over the total nuclear areas in 10 section fields.

Centri partecipanti

Nord Italia

E.O. OSPEDALI GALLIERA - GENOVA
Via Mura delle Cappuccine 14 - 16128 Genova - GE

Riferimento: Prof. Andrea De Censi
Telefono: 0105634501
Email: andrea.decensi@galliera.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2015-004824-77

Data di inserimento: 05.02.2019

Promotore

Ente Ospedaliero Ospedali Galliera

CRO

/

Principal Investigator ITALIA

Ente Ospedaliero Ospedali Galliera

Riferimento: Prof. Andrea De Censi

Telefono: 0105634501

Email: andrea.decensi@galliera.it

Localita: Genova

 

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