Actively Recruiting
Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-12-20
446
Participants Needed
16
Research Sites
390 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the interest of regorafenib in combination of metronomic chemotherapies and low-dose aspirin as a 2 months induction therapy before chemotherapy initiation in the second-line metastatic colorectal carcinoma
CONDITIONS
Official Title
Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic colorectal cancer progressing after first-line chemotherapy with or without targeted therapy
- Prior first-line treatment with regimens such as FOLFOX, FOLFIRI, FOLFIRINOX, or combinations with bevacizumab or anti-EGFR
- History of resistance to first-line chemotherapy defined by disease progression during or soon after initial treatment or relapse within 6 months after adjuvant therapy or surgery
- Life expectancy of at least 3 months
- Age 18 years or older, any gender
- ECOG performance status of 0 or 1
- Measurable disease according to RECIST v1.1 criteria
- Microsatellite-stable status, absence of BRAF V600E mutation, and known RAS status
- Adequate bone marrow, liver and kidney function with specific laboratory thresholds
- No contraindication to iodine contrast for CT scans
- Negative pregnancy test for women of childbearing potential and use of effective contraception
- Signed informed consent and ability to comply with study protocol
- Registered in a national health care system
You will not qualify if you...
- Diagnosis of another cancer within 2 years except certain skin and cervical/bladder cancers
- Current participation in another investigational study or recent investigational drug use
- Psychological, social, or geographical factors impairing study compliance
- Under legal protection or deprived of freedom
- Planned surgery or procedures affecting treatment timing within first month
- Prior exposure to regorafenib or anti-angiogenic treatments other than bevacizumab
- Complete deficiency in dihydropyrimidine dehydrogenase (DPD)
- Major surgery, open biopsy, or significant injury within 28 days before study
- Pregnant or breastfeeding
- Significant heart conditions including congestive heart failure NYHA class 2 or greater, unstable angina, recent myocardial infarction, or arrhythmias requiring treatment
- Uncontrolled hypertension or history of hypertensive crisis
- Pleural effusion or ascites causing breathing problems
- Active infection grade above 2
- HIV infection or active/chronic hepatitis B or C requiring treatment
- Seizure disorders requiring medication
- History of organ transplant
- History or evidence of bleeding disorders or recent serious bleeding events
- Non-healing wounds, active ulcers, or untreated fractures
- Recent abdominal fistula, gastrointestinal perforation, abscess, or bleeding
- Dehydration grade 1 or greater
- Known hypersensitivity to study drugs or excipients
- Interstitial lung disease with symptoms
- Persistent severe proteinuria
- Inability to swallow oral medication
- Malabsorption conditions or unresolved significant toxicity to prior therapies
- Recent systemic anticancer therapy within 3 weeks
- Recent investigational drug use within 28 days except aspirin
- Use of drugs interacting with regorafenib metabolism enzymes CYP3A4 or UGT1A9
AI-Screening
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Trial Site Locations
Total: 16 locations
1
CHU de Besançon
Besançon, France
Actively Recruiting
2
CHU Estain
Clermont-Ferrand, France
Not Yet Recruiting
3
Hôpital Henri Mondor
Créteil, France
Actively Recruiting
4
Centre Georges François Leclerc
Dijon, France
Actively Recruiting
5
Centre Léon Bérard
Lyon, France, 69000
Not Yet Recruiting
6
Hôpital Privé Jean Mermoz
Lyon, France
Actively Recruiting
7
Hôpital Nord Franche Comté
Montbéliard, France
Actively Recruiting
8
CHU Montpellier
Montpellier, France
Actively Recruiting
9
Groupe hospitalier de la région de Mulhouse et Sud Alsace
Mulhouse, France
Actively Recruiting
10
Centre Antoine Lacassagne
Nice, France
Not Yet Recruiting
11
Hôpital Européen Georges Pompidou
Paris, France
Actively Recruiting
12
Hôpital la Pitié-Salpétrière
Paris, France
Actively Recruiting
13
Hôpital Saint antoine
Paris, France
Actively Recruiting
14
Institut Mutualiste Montsouris
Paris, France
Actively Recruiting
15
CHU de Reims - Hôpital Robert Debré
Reims, France
Actively Recruiting
16
Hôpital FOCH
Suresnes, France
Not Yet Recruiting
Research Team
A
Angélique VIENOT, MD, PhD
CONTACT
C
Christophe BORG, MD, PhD
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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