Actively Recruiting
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
Led by Institut Paoli-Calmettes · Updated on 2021-05-06
39
Participants Needed
2
Research Sites
359 weeks
Total Duration
On this page
Sponsors
I
Institut Paoli-Calmettes
Lead Sponsor
U
University of California, Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
CONDITIONS
Official Title
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old.
- Diagnosis of histologically confirmed rectal adenocarcinoma for which neoadjuvant chemoradiation therapy has been indicated.
- Karnofsky Performance Score (KPS) of 70 or higher or ECOG performance status of 0 or 1.
- Signed consent to participate.
- Women of childbearing age must agree to use effective contraception during treatment.
- Affiliated with or beneficiary of a social security regimen.
You will not qualify if you...
- Predominant mucinous component on initial MRI, biopsy, or pathology.
- Contraindications to MRI (e.g., incompatible pacemaker, metallic foreign body, severe claustrophobia).
- Receiving radiation therapy alone.
- Receiving other associated neoadjuvant treatments.
- Surgery delayed more than approximately 10 weeks after neoadjuvant chemoradiation or surgery canceled.
- Contraindications to capecitabine (severe liver or kidney impairment).
- Known deficiency of Dihydropyrimidine dehydrogenase (DPD) or hypersensitivity to 5-FU/capecitabine or its components.
- Participation in another protocol with concurrent treatment.
- Pregnant, likely to be pregnant without effective contraception, or breastfeeding.
- Person in emergency situation, under legal protection, or unable to give consent.
- Unable to attend medical examinations due to geographical, social, or psychological reasons.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095-1406
Not Yet Recruiting
2
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, France, 13009
Actively Recruiting
Research Team
D
Dominique GENRE, MD
CONTACT
M
Margot BERLINE, MSc, MBA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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