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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03961776

Acronym

DWI_RECT_MRGRT

Enrollment

Registered

2019-05-23

Start date

2020-06-08

Completion date

2027-05-31

Last updated

2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Adenocarcinoma

Keywords

Diffusion weighted imaging, Radiation therapy

Brief summary

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

DEVICEMRI-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

France, United States

Contacts

Primary ContactDominique GENRE, MD

DRCI.UP@ipc.unicancer.fr33491223778

Backup ContactMargot BERLINE, MSc, MBA