Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems

Recruiting now

Conditions studied: Rectal Adenocarcinoma

In brief

feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.

Key facts

Study ID

NCT03961776

Run by

Institut Paoli-Calmettes

People needed

39

Starts

2020-06-08

Expected to finish

2027-05-01

Last updated by the study team

2021-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Institut Paoli Calmettes — Marseille, Bouches Du Rhone, France (enrolling)
• University of California Los Angeles (UCLA) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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