RecruitingNCT03961776

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

Sponsor

Institut Paoli-Calmettes

Enrollment

39 participants

Start Date

Jun 8, 2020

Study Type

OBSERVATIONAL

Conditions

Rectal Adenocarcinoma

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria11

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.

Interventions

DEVICEMRI-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.