Tests regorafenib as second-line treatment for RAS-mutant advanced colorectal cancer
Tests regorafenib in adults with RAS-mutant metastatic colorectal cancer after first-line treatment.
Plain-language title generated from the registry record
Registry title: STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer
Key facts
- Where
- Avellino, Caserta, Località la Schiana, Pozzuoli (NA), Naples, Napoli, Potenza, San Giovanni Rotondo, and Tricase, ItalySee the 9 sites
- Phase
- Phase 2
Where in Italy
- AORN San Giuseppe Moscati AvellinoAvellino, ItalyTaking people
- Azienda Ospedaliera San'Anna e San Sebastiano di CasertaCaserta, ItalyTaking people
- Presidio Ospedaliero Santa Maria delle GrazieLocalità la Schiana, Pozzuoli (NA), ItalyTaking people
- Azienda Ospedaliera dei ColliNaples, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Azienda ospedaliero universitaria -Universita degli Studi della Campania Luigi VanvitelliNapoli, ItalyTaking people
- Azienda Ospedaliera Regionale San CarloPotenza, ItalyTaking people
- Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
- Pia Fondazione Di Culto E Religione Card G PanicoTricase, ItalyTaking people
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
- National Cancer Institute, Naples
- Trial code
- NCT07213570EU 2024-519669-23-00
- Record updated
- 13 October 2026
- Original description
The investigators hypothesize that patients with mCRC RAS-mutant eligible for a second line treatment with good prognostic features, identified as single metastatic site, long progression free survival (PFS) in first line treatment, might benefit from a personalized approach, with less intensive treatment with regorafenib as part of a continuum-of-care strategy aimed at ensuring quality of life and extending survival.Read full original descriptionShow less
Regorafenib as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer: a Multicentre, Phase 2 Study
The investigators hypothesize that patients with mCRC RAS-mutant eligible for a second line treatment with good prognostic features, identified as single metastatic site, long progression free survival (PFS) in first line treatment, might benefit from a personalized approach, with less intensive treatment with regorafenib as part of a continuum-of-care strategy aimed at ensuring quality of life and extending survival.
Inclusion: Written informed consent to study procedures and to correlative studies; Either sex aged ≥ 18; Histologically proven of colorectal adenocarcinoma; Diagnosis of metastatic disease; RAS mutant at initial diagnosis assessed at local centers according with a validated method defined by EMA and known MMR/MSI status; Achieved a PFS in first line > 6 months with chemotherapy in combination to antiangiogenic treatment OR with one metastatic site at study entry; Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry; Imaging-documented measurable disease, according to RECIST 1.1 criteria; Estimated life expectancy of more than 12 weeks; Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL; Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN; Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula); Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range; Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory. Additional analysis of polymorphisms uridine diphosphate-glycosyltransferase 1 (UGT1A1) enzyme is recommended but not mandatory.
Exclusion: Not received immunotherapy if dMMR or MSI-H; Major surgical intervention within 4 weeks prior to enrollment; Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study; Participation in any interventional drug or medical device study within 30 days prior to treatment start; Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form; Any contraindication to regorafenib; Pregnancy and breast-feeding; Any brain metastasis; Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment; Complete deficiency of activity of dihydropyrimidine dehydrogenase (DPYD).