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NCT Number: NCT03961776

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli Calmettes, Marseille, Bouches Du Rhone, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI-guided radiotherapy by on-board DWI sequences

Device

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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique GENRE, MD

CONTACT

[email protected]

33491223778

Margot BERLINE, MSc, MBA

CONTACT

[email protected]

33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Collaborators

  • University of California, Los Angeles

Registry information

Acronym: DWI_RECT_MRGRT

Important dates

Study start
2020
Primary completion
2022
Study completion
2027
First posted
May 23, 2019
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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