What is Regorafenib studying for metastatic colorectal cancer?

Regorafenib is being studied to see if combining it with metronomic chemotherapy and low-dose aspirin improves progression-free survival compared to Regorafenib alone in patients with chemo-resistant metastatic colorectal cancer. This research is conducted to explore new treatment options for patients whose cancer has progressed after standard therapies. The trial is sponsored by Centre Hospitalier Universitaire de Besancon.

Who may be eligible for this metastatic colorectal cancer clinical trial?

Adults aged 18 years or older with metastatic colorectal cancer that has progressed after standard treatments may be eligible. Both men and women can participate if they have a good performance status and adequate organ function. Certain prior treatments and health conditions may exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic colorectal cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06425133

Impact of Regorafenib Combined With Metronomic Chemotherapy and Low-Dose Aspirin on Progression-Free Survival Compared With Standard Regorafenib in Chemo-Resistant Metastatic Colorectal Cancer

Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-12-24

174

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of combining Regorafenib with metronomic chemotherapy capecitabine and cyclophosphamide and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer who are resistant to chemotherapy. This phase 2 randomized trial aims to assess progression-free survival as the main outcome to better understand treatment impact in this patient group. Participants are assigned to one of two groups one receives Regorafenib alone, and the other receives Regorafenib plus metronomic chemotherapy and low-dose aspirin. Regorafenib is given 3 weeks out of every 4-week cycle, starting with a stepwise dosing schedule in the first cycle and then continuing at adjusted doses based on tolerance. The combination group receives cyclophosphamide daily for 6 months, capecitabine twice daily for 6 months, and aspirin daily until disease progression. During the study, participants undergo blood sampling for plasma and circulating tumor DNA analysis, fresh tumor biopsies at baseline and week 8, and complete quality of life questionnaires at multiple times including baseline and follow-up visits. Researchers monitor safety, treatment effects, and progression-free survival over time. The total participation duration varies depending on individual disease progression and tolerance to treatments.

CONDITIONS

Brief Title

Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients with histologically confirmed metastatic colorectal cancer progressing after standard 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 criteria
Adequate bone marrow, liver, and kidney function
No contraindication to iodine contrast media for CT scans
Negative pregnancy test for women of childbearing potential and use of adequate birth control
Signed informed consent
Ability to comply with study protocol
Registered in a national health care system

You will not qualify if you...

Diagnosis of another malignancy within 2 years, except certain treated skin or cervical/bladder cancers
Participation in another investigational drug study or within exclusion period
Conditions affecting compliance including psychological, social, or geographical issues
Under judicial protection or deprived of freedom
Previous exposure to regorafenib or certain anti-angiogenic treatments
Use of other investigational drugs within 28 days except aspirin
Receiving systemic anticancer therapy within 3 weeks
Chronic use of drugs interacting with regorafenib or epilepsy medication
Complete deficiency in dihydropyrimidine dehydrogenase (DPD)
Known hypersensitivity to study drugs or excipients
Unresolved toxicity higher than grade 1 from prior therapies
Inability to swallow oral medication or malabsorption
Significant cardiac, respiratory, or uncontrolled infection conditions
Recent serious bleeding or surgical procedures
Planned surgery within first month of treatment
HIV infection or active hepatitis B/C requiring treatment
Recent yellow fever vaccination
History of organ transplant
Pregnant or breastfeeding women

Research Team

Angélique VIENOT, Dr

Christophe BORG, Pr

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