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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 (DWI_RECT_MRGRT)

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ClinicalTrials.gov Identifier: NCT03961776
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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

Condition or disease Intervention/treatment
Rectal Adenocarcinoma Device: MRI-guided radiotherapy by on-board DWI sequences

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

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Study Type : Observational
Estimated Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2026
Estimated Study Completion Date : February 28, 2026

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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961776


Contacts
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Contact: Dominique GENRE, MD 33491223778 DRCI.UP@ipc.unicancer.fr
Contact: Margot BERLINE, MSc, MBA 33491223778 DRCI.UP@ipc.unicancer.fr

Locations
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United States, California
University of California Los Angeles (UCLA) Not yet recruiting
Los Angeles, California, United States, 90095-1406
Contact: Percy LEE, MD         
Principal Investigator: Percy LEE         
France
Institut Paoli Calmettes Not yet recruiting
Marseille, Bouches Du Rhone, France, 13009
Contact: Dominique Genre, MD    0033491223778    drci.up@ipc.unicancer.fr   
Principal Investigator: Marguerite TYRAN         
Sponsors and Collaborators
Institut Paoli-Calmettes
University of California, Los Angeles
Investigators
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Principal Investigator: Marguerite TYRAN, MD Institut Paoli-Calmettes

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03961776     History of Changes
Other Study ID Numbers: DWI_RECT_MRGRT-IPC 2019-002
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Institut Paoli-Calmettes:
Diffusion weighted imaging
Radiation therapy

Additional relevant MeSH terms:
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Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases