Actively Recruiting
Impact of Regorafenib with Metronomic Chemotherapy and Low-Dose Aspirin Compared to Standard Regorafenib for Chemo-Resistant Metastatic Colorectal Cancer Evaluating Progression-Free Survival
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
Researchers are evaluating the effect of combining Regorafenib with metronomic chemotherapy and low-dose aspirin versus using standard Regorafenib treatment alone in patients with metastatic colorectal cancer that is resistant to chemotherapy. This phase 2 study aims to compare the progression-free survival between these two treatment approaches to understand if the combination offers any benefit. Participants receive Regorafenib following a special dosing schedule called "REDOS" during the first cycle, gradually increasing doses over three weeks then taking a week off. After the first cycle, the dose is adjusted based on tolerance. In the combination group, patients also take daily metronomic chemotherapy drugs cyclophosphamide and capecitabine for six months, along with low-dose aspirin until disease progression. The treatment continues until unacceptable side effects or cancer progression. During the study, participants undergo blood samples for plasma and circulating tumor DNA, as well as fresh tumor biopsies at baseline and week 8. Quality of life is assessed repeatedly using specific questionnaires at multiple time points up to one year and at treatment end and follow-up visits. Researchers monitor progression-free survival as the primary outcome, with safety and treatment tolerability tracked throughout. The total study duration includes treatment and follow-up phases, ensuring comprehensive assessment of effects and patient well-being.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
C
Christophe BORG, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here