Recruiting NCT03961776
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI-guided radiotherapy by on-board DWI sequences.
- Who it may be relevant to
- Registry conditions: Rectal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
Detailed description
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
Interventions
- Device 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.
Primary outcome measures
- Predictive value of Apparent Diffusion Coefficient measured using MRgRT system [Time frame: At surgery (5 to 10 weeks after completion of chemoradiation)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California Los Angeles (UCLA) — Los Angeles
France · 1 center
- Institut Paoli Calmettes — Marseille
Identifiers
NCT: NCT03961776 · DWI_RECT_MRGRT-IPC 2019-002