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

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Recruiting

CT.gov ID

NCT03961776

Collaborator

University of California, Los Angeles (Other)

Enrollment

Locations

82.7

Anticipated Duration (Months)

19.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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

Actual Study Start Date :

Jun 8, 2020

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles (UCLA)	Los Angeles	California	United States	90095-1406
2	Institut Paoli Calmettes	Marseille	Bouches Du Rhone	France	13009

Sponsors and Collaborators

Institut Paoli-Calmettes
University of California, Los Angeles

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Paoli-Calmettes

ClinicalTrials.gov Identifier:

NCT03961776

Other Study ID Numbers:

DWI_RECT_MRGRT-IPC 2019-002

First Posted:

May 23, 2019

Last Update Posted:

May 6, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

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:

Adenocarcinoma

Rectal Neoplasms

Study Results

No Results Posted as of May 6, 2021