Actively Recruiting
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-12-24
174
Participants Needed
10
Research Sites
215 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Besancon
Lead Sponsor
G
Groupement Interrégional de Recherche Clinique et d'Innovation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective is to evaluate the impact of a Regorafenib combined with metronomic chemotherapy (capecitabine and cyclophosphamide) and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer by assessing progression-free survival.
CONDITIONS
Official Title
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic colorectal cancer progressing after previous standard treatments including 5FU, Irinotecan, oxaliplatin, anti-VEGF, trifluridine/tipiracil, anti-EGFR if KRAS and NRAS wild type, anti-BRAF if BRAF V600E mutated, and anti-PD1 if MSI-H/dMMR, or not candidates for these treatments
- Life expectancy of at least 3 months
- Male or female aged over 18 years
- Performance status of 0 or 1
- Measurable disease by RECIST v1.1 on scanner or MRI
- Adequate bone marrow, liver, and kidney function as defined by specific laboratory thresholds
- No contraindication to iodine contrast media injection during CT
- Negative pregnancy test within 14 days before starting for women of childbearing potential
- Men and women must use adequate birth control during the study if applicable
- Signed and dated informed consent
- Ability to comply with study protocol
- Registered in a national healthcare system (including CMU)
You will not qualify if you...
- Diagnosis of another cancer within 2 years prior except certain treated skin, cervical, or bladder cancers
- Participation in another investigational study or within exclusion period
- Psychological, familial, sociological, or geographical conditions that may impair compliance
- Under judicial protection or deprived of freedom
- Previous exposure to regorafenib or anti-angiogenic treatments other than bevacizumab and aflibercept
- Treatment with other investigational drugs within 28 days prior except aspirin
- Systemic anticancer therapy within 3 weeks before study
- Chronic treatment with drugs interacting with regorafenib or certain neurological conditions
- Complete deficiency of dihydropyrimidine dehydrogenase (DPD)
- Known hypersensitivity to study drugs or related compounds including severe reactions to fluoropyrimidines or aspirin-induced asthma
- Unresolved toxicity above grade 1 from prior therapy except specific conditions
- Inability to swallow oral medications or malabsorption
- Inadequate organ function including unstable heart or respiratory failure, uncontrolled hypertension, active infections, or severe dehydration
- Bleeding disorders or recent significant hemorrhage
- Recent major surgery or trauma within 28 days
- Planned surgery within first treatment month
- HIV infection or active/chronic hepatitis B or C requiring treatment
- Receipt of yellow fever vaccine within 28 days prior
- History of organ transplant
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 10 locations
1
CHU d'Auxerre
Auxerre, France
Actively Recruiting
2
Centre Hospitalier Universitaire de Besançon
Besançon, France, 25000
Actively Recruiting
3
CH de Colmar
Colmar, France
Actively Recruiting
4
Centre Georges-François Leclerc (CGFL)
Dijon, France
Actively Recruiting
5
Hôpital Robert Schuman
Metz, France
Actively Recruiting
6
Hôpital Nord Franche-Comté
Montbéliard, France
Actively Recruiting
7
CHU de Montpellier
Montpellier, France
Actively Recruiting
8
CHU de Reims - Hôpital Robert Debré
Reims, France
Actively Recruiting
9
Clinique Privée de Strasbourg
Strasbourg, France
Not Yet Recruiting
10
ICANS
Strasbourg, France
Actively Recruiting
Research Team
A
Angélique VIENOT, Dr
CONTACT
C
Christophe BORG, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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