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New treatment option for Colorectal Cancer Metastatic
Official title STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer
ClinicalTrials.gov ID: NCT07213570
What this study is testing
What is standard second line treatment, at discretion of the investigator?
standard second line treatment, at discretion of the investigator is an investigational medicine, being studied as a potential treatment for colorectal cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone...
- Any contraindication to regorafenib.
- Not received immunotherapy if dMMR or MSI-H.
- Major surgical intervention within 4 weeks prior to enrollment.
- Pregnancy and breast-feeding.
- Any brain metastasis.
See the full eligibility criteria
- 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.
- 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.
- Pregnancy and breast-feeding.
- Any brain metastasis.
- 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...
- 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.
- Participation in any treatment drug or medical device study within 30 days prior to treatment start.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.