Using MRI to Monitor Treatment Response in Rectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the feasibility of utilizing diffusion-weighted imaging (DWI) within a magnetic resonance-guided radiotherapy (MRgRT) system to assess early treatment responses in patients undergoing neoadjuvant chemotherapy and radiation for rectal adenocarcinoma. By monitoring changes in tumor characteristics during treatment, the study aims to identify potential markers that could indicate how well the therapy is working. The approach involves patients receiving MRI-guided radiotherapy while their treatment response is evaluated through on-board DWI sequences.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient over 18 years old.
2. Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.
3. Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1
4. Signed consent to participation.
5. For women of childbearing age, effective contraception must also be agreed for the duration of treatment.
6. Affiliation to a social security regimen, or beneficiary of such a regimen.

Exclusion Criteria:

1. Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.
2. Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).
3. Exclusive radiation therapy.
4. Other associated neo-adjuvant treatment.
5. Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.
6. Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance \<30 ml / min),
7. Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU / capecitabine and / or its excipients.
8. Participation in a protocol with concurrent treatment.
9. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding
10. Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent.
11. Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.

Where it's running

• Institut Paoli Calmettes
  Marseille, Bouches Du Rhone, France Recruiting
• University of California Los Angeles (UCLA)
  Los Angeles, California, United States Not yet recruiting

Study contacts

• Principal investigator: Marguerite TYRAN, MD — Institut Paoli-Calmettes
• Study coordinator: Dominique GENRE, MD
• Email: DRCI.UP@ipc.unicancer.fr
• Phone: 33491223778

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.