RECRUITING

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

Conditions

Rectal Adenocarcinoma Diffusion weighted imaging Radiation therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2020-06-08

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03961776

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Dominique GENRE, MD

CONTACT

33491223778

DRCI.UP@ipc.unicancer.fr

Margot BERLINE, MSc, MBA

CONTACT

33491223778

DRCI.UP@ipc.unicancer.fr

Principal Investigator

Marguerite TYRAN, MD

PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Study Locations (Sites)

University of California Los Angeles (UCLA)

Los Angeles, California, 90095-1406

United States

Collaborators and Investigators

Sponsor: Institut Paoli-Calmettes

Marguerite TYRAN, MD, PRINCIPAL_INVESTIGATOR, Institut Paoli-Calmettes

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-08

Study Completion Date2027-05

Study Record Updates

Study Start Date2020-06-08

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

Diffusion weighted imaging
Radiation therapy

Additional Relevant MeSH Terms

Rectal Adenocarcinoma