Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
NCT ID: NCT03961776
Last Updated: 2021-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
39 participants
OBSERVATIONAL
2020-06-08
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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non-metastatic rectal adenocarcinoma nRCT indicated
Patients with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Institut Paoli-Calmettes
OTHER
Responsible Party
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Principal Investigators
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Marguerite TYRAN, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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University of California Los Angeles (UCLA)
Los Angeles, California, United States
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, France
Countries
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Central Contacts
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Facility Contacts
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Percy LEE, MD
Role: primary
Other Identifiers
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DWI_RECT_MRGRT-IPC 2019-002
Identifier Type: -
Identifier Source: org_study_id
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