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

Rectal Adenocarcinoma Clinical Trial

— DWI_RECT_MRGRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961776
• Other study ID #: DWI_RECT_MRGRT-IPC 2019-002
• Status: Recruiting
• Start date: June 8, 2020
• Est. completion date: May 2027

Study information

• Verified date: May 2021
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: 33491223778
• Email: DRCI.UP[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: May 2027
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Adenocarcinoma
• Rectal Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone
United States	University of California Los Angeles (UCLA)	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	University of California, Los Angeles

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of Apparent Diffusion Coefficient measured using MRgRT system	Pathological complete response using AJCC criteria	At surgery (5 to 10 weeks after completion of chemoradiation)