STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples

About this trial

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.

Eligibility criteria

Qualifiers

Written informed consent to study procedures and to correlative studies.

Either sex aged ≥ 18.

Histologically proven of colorectal adenocarcinoma.

Diagnosis of metastatic disease.

Disqualifiers

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.

Any contraindication to regorafenib.

Not received immunotherapy if dMMR or MSI-H.

Major surgical intervention within 4 weeks prior to enrollment.

Trial design

Treatments tested in this trial

  • standard second line treatment, at discretion of the investigator
  • Regorafenib (BAY73-4506)

Treatment groups

60 Participants
are divided into 2 treatment groups