Ireland
--:--IST
Recruiting Observational

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

NCT03961776 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2020-06-08
Last updated
2021-05-06

Condition(s) studied

Rectal Adenocarcinoma

Investigational drug(s) / intervention(s)

MRI-guided radiotherapy by on-board DWI sequences

MRI-guided radiotherapy by on-board DWI sequences: The radiotherapy treatment will be delivered on the MRI-guided radiotherapy platform. The on-board DWI sequences will be performed every three fractions in addition to the treatment session and will last approximately 3-4 minutes.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Predictive value of Apparent Diffusion Coefficient measured using MRgRT system — At surgery (5 to 10 weeks after completion of chemoradiation)
    Pathological complete response using AJCC criteria

Trial sites (2)

FacilityCityRegionStatus
University of California Los Angeles (UCLA) Los Angeles California Not Yet Recruiting
Institut Paoli Calmettes Marseille Bouches Du Rhone Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03961776 on ClinicalTrials.gov ↗ ← All trials in France