Clinical trial NCT03961776: Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
Official title: Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Adenocarcinoma
Keywords: Diffusion weighted imaging
Radiation therapy
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2019-05-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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

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

Eligibility 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.

Primary outcomes:
measure: Predictive value of Apparent Diffusion Coefficient measured using MRgRT system
timeFrame: At surgery (5 to 10 weeks after completion of chemoradiation)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Marguerite TYRAN, MD
role: PRINCIPAL_INVESTIGATOR
References: