Rectal AdenocarcinomaDWI_RECT_MRGRTNCT03961776
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
An observational study of Rectal Adenocarcinoma, run by Institut Paoli-Calmettes at 2 sites in 2 countries.
Trial summary
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- MRI-guided radiotherapy by on-board DWI sequences
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Jun 2020to May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
University of California Los Angeles (UCLA)
Los Angeles, California, 90095-1406
Percy LEE, MD
Percy LEE
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, 13009
Dominique Genre, MD, 0033491223778, drci.up@ipc.unicancer.fr
Caroline Gouarné, PhD, 0033491223778, drci.up@ipc.unicancer.fr
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.
Read the detailed description
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- MRI-guided radiotherapy by on-board DWI sequences
- Keywords
- Diffusion weighted imaging, Radiation therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided radiotherapy by on-board DWI sequencesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| non-metastatic rectal adenocarcinoma nRCT indicated | Patients with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated. Receives: Device: MRI-guided radiotherapy by on-board DWI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of Apparent Diffusion Coefficient measured using MRgRT system
Pathological complete response using AJCC criteria
Measured: At surgery (5 to 10 weeks after completion of chemoradiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start8 Jun 2020
- Primary completionMay 2022 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Marguerite TYRAN, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961776
- Sponsor's protocol ID
- DWI_RECT_MRGRT-IPC 2019-002
- Acronym
- DWI_RECT_MRGRT
- Status last verified
- May 2021
- First submitted
- 20 May 2019
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No