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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MRI-guided radiotherapy by on-board DWI sequences

    Device

    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.

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: non-metastatic rectal adenocarcinoma nRCT indicated1 intervention

Trial outcomes

Primary outcomes

1

Predictive value of Apparent Diffusion Coefficient measured using MRgRT system

Pathological complete response using AJCC criteria

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Institut Paoli-Calmettes

Lead sponsor

University of California, Los Angeles

Collaborator