NCT03961776

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jun 2020May 2027

First Submitted

Initial submission to the registry

May 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

May 20, 2019

Last Update Submit

May 5, 2021

Conditions

Rectal Adenocarcinoma

Keywords

Diffusion weighted imagingRadiation therapy

Outcome Measures

Primary Outcomes (1)

  • Predictive value of Apparent Diffusion Coefficient measured using MRgRT system

    Pathological complete response using AJCC criteria

    At surgery (5 to 10 weeks after completion of chemoradiation)

Study Arms (1)

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

Interventions

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.

non-metastatic rectal adenocarcinoma nRCT indicated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California Los Angeles (UCLA)

Los Angeles, California, 90095-1406, United States

NOT YET RECRUITING

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Marguerite TYRAN, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, MD

CONTACT

33491223778DRCI.UP@ipc.unicancer.fr

Margot BERLINE, MSc, MBA

CONTACT

33491223778DRCI.UP@ipc.unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 23, 2019

Study Start

June 8, 2020

Primary Completion

May 1, 2022

Study Completion (Estimated)

May 1, 2027

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)US(1)