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NCT03961776 | RECRUITING | Rectal Adenocarcinoma

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

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

Rectal Adenocarcinoma

Intervention/treatment

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 Type : OBSERVATIONAL
Estimated Enrollment : 39 participants
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 : 2020-06-08
Estimated Primary Completion Date : 2022-05
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems

Location Details

NCT03961776

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Locations

NOT YET RECRUITING

United States, California

University of California Los Angeles (UCLA)

Los Angeles, California, United States, 90095-1406

RECRUITING

France, Rhone mouths

Institut Paoli CALMETTES

Marseille, Bouches du Rhone, France, 13009