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

May 5, 2021 updated by: Institut Paoli-Calmettes
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
        • Principal Investigator:
          • Marguerite TYRAN
  • United States
    • California
      • Los Angeles, California, United States, 90095-1406
        • Not yet recruiting
        • University of California Los Angeles (UCLA)
        • Contact:
          • Percy LEE, MD
        • Principal Investigator:
          • Percy LEE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of men and / or women over 18 years of age, with no upper limit age, with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-metastatic rectal adenocarcinoma nRCT indicated
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Collaborators

University of California, Los Angeles

Investigators

  • Principal Investigator: Marguerite TYRAN, MD, Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2020

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2027

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DWI_RECT_MRGRT-IPC 2019-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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