Adjuvant therapy in stage IV colorectal cancer patients NED
Key facts
- Where
- Bari, Belluno, Bergamo, Genoa, Legnago, Monza, Naples, Padova, Pisa, Potenza, Rome és Udine, OlaszországSee the 12 sites
- Phase
- 2. fázis
Where in Olaszország
- Istituto Tumori Bari Giovanni Paolo IIBari, OlaszországNo longer taking part
- Azienda Unita Locale Socio Sanitaria N. 1 DolomitiBelluno, OlaszországNo longer taking part
- Cliniche Gavazzeni S.p.A.Bergamo, OlaszországNo longer taking part
- IRCCS Ospedale Policlinico San MartinoGenoa, OlaszországNo longer taking part
- Azienda Ulss 9 ScaligeraLegnago, OlaszországNo longer taking part
- Fondazione IRCCS San Gerardo dei TintoriMonza, OlaszországNo longer taking part
- Azienda Sanitaria Locale Napoli 1 CentroNaples, OlaszországNo longer taking part
- Istituto Oncologico VenetoPadova, OlaszországNo longer taking part
- Azienda Ospedaliero Universitaria PisanaPisa, OlaszországNo longer taking part
- Azienda Ospedaliera Regionale San CarloPotenza, OlaszországNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországNo longer taking part
- Azienda Sanitaria Universitaria Friuli CentraleUdine, 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 Ospedale Policlinico San Martino
- Trial code
- EU 2024-518217-26-00
- Record updated
- 2024. október 28.
- Original description
Disease Free Survival (DFS)Read full original descriptionShow less
A randomized, phase IIb study of adjuvant durvalumab (MEDI4736) plus regorafenib vs untreated control in stage IV colorectal cancer patients with no evidence of disease (NED): VIVA trial
Disease Free Survival (DFS)
Inclusion: ≥ 18 years; Histologically confirmed diagnosis of colorectal adenocarcinoma; Patients must be in NED after completion of any treatments for stage IV CRC, including resections, RFA; RT with or without neoadjuvant/adjuvant therapies or CR after chemotherapy; NED state ascertained by means of CT scan and/or PET scan and/or MRI scan; Patients must be randomized within 10 weeks since the achievement of the NED state. Those who have also received adjuvant therapy following the locoregional treatment or those who achieved complete response on systemic therapies are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle.
Exclusion: Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment; Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable; Any form of systemic disease that, in the opinion of the Investigator, would make the subject unsuitable for the study (including autoimmunity) or would prevent compliance with the study protocol; Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria; Patients with microsatellite instability (MSI) or DNA Mismatch Repair Deficiency (dMMR) are not allowed.