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

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

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

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

Conditions
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Rectal Adenocarcinoma

Intervention / Treatment
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* Device: MRI-guided radiotherapy by on-board DWI sequences


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-metastatic rectal adenocarcinoma nRCT indicated<br>Patients with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated. | Device: MRI-guided radiotherapy by on-board DWI sequences<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of Apparent Diffusion Coefficient measured using MRgRT system | Pathological complete response using AJCC criteria | At surgery (5 to 10 weeks after completion of chemoradiation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffusion weighted imaging, Radiation therapy