REVOLUTION - Randomized phasE 2 study of Valproic acid in combination with bevacizumab and Oxaliplatin/fLUoropyrimidine regimens in patients with ras-mutated metastaTIc cOlorectal caNcer
Key facts
- Where
- Bari, Foggia, Località la Schiana, Pozzuoli (NA), Naples, Palermo, Potenza, Tricase és Vicenza, OlaszországSee the 8 sites
- Phase
- 2. fázis
Where in Olaszország
- Istituto Tumori Bari Giovanni Paolo IIBari, OlaszországNo longer taking part
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, OlaszországNo longer taking part
- Presidio Ospedaliero Santa Maria delle GrazieLocalità la Schiana, Pozzuoli (NA), OlaszországNo longer taking part
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, OlaszországNo longer taking part
- Casa di Cura Macchiarella-PalermoPalermo, OlaszországNo longer taking part
- Azienda Ospedaliera Regionale San CarloPotenza, OlaszországNo longer taking part
- Pia Fondazione Di Culto E Religione Card G PanicoTricase, OlaszországNo longer taking part
- Azienda Unita Locale Socio Sanitaria N 8 BericaVicenza, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Trial code
- EU 2024-516844-25-01
- Record updated
- 2026. szeptember 1.
- Original description
To test whether the combination of valproic acid with bevacizumab and oxaliplatin/fluoropyrimidine regimens (mFOLFOX6/mOXXEL) can prolong progression free survival (PFS) as compared with bevacizumab and oxaliplatin/fluoropyrimidine regimens alone as first-line treatment in patients with metastatic colorectal cancer with mutation of RAS.Read full original descriptionShow less
To test whether the combination of valproic acid with bevacizumab and oxaliplatin/fluoropyrimidine regimens (mFOLFOX6/mOXXEL) can prolong progression free survival (PFS) as compared with bevacizumab and oxaliplatin/fluoropyrimidine regimens alone as first-line treatment in patients with metastatic colorectal cancer with mutation of RAS.
Inclusion: Age = 18 • Histologically confirmed diagnosis of colorectal adenocarcinoma • Stage IV of disease (according to TNM 8th edition) • RAS mutations • Clinical or radiologic evidence of disease (at least one target according to RECIST 1.1) • ECOG performance status 0 to 1 • Life expectancy > 3 months • Use of an acceptable mean of contraception for men and women of childbearing potential • Adequate recovery from previous surgery. At least 28 days should elapse from a surgical procedure or from performing a biopsy for the enrolment into the study • Written informed consent.
Exclusion: Tumors without RAS mutations • Prior chemotherapy or any other medical treatment for advanced mCRC (previous adjuvant chemotherapy is allowed if ended > 6 months before relapse or > 24 months if the adjuvant treatment included oxaliplatin) • Radiotherapy to any site for any reason within 28 days prior to randomization (palliative radiotherapy to bone lesions is allowed if = 14 days before randomization) • Any other invasive malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA) • Patient who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid • Known dihydropyrimidine dehydrogenase (DPD) deficiency • Pregnancy or nursing • Concomitant pathologies or laboratory alterations or concomitant medications use that prevent or contraindicate the use of study drugs • Brain metastases.