NCT03961776 Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
| NCT ID | NCT03961776 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Paoli-Calmettes |
| Condition | Rectal Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 39 participants |
| Start Date | 2020-06-08 |
| Primary Completion | 2022-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 39 participants in total. It began in 2020-06-08 with a primary completion date of 2022-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Contact & Investigator
Marguerite TYRAN, MD
PRINCIPAL INVESTIGATOR
Institut Paoli-Calmettes
Frequently Asked Questions
Who can join the NCT03961776 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03961776 currently recruiting?
Yes, NCT03961776 is actively recruiting participants. Contact the research team at DRCI.UP@ipc.unicancer.fr for enrollment information.
Where is the NCT03961776 trial being conducted?
This trial is being conducted at Los Angeles, United States, Marseille, France.
Who is sponsoring the NCT03961776 clinical trial?
NCT03961776 is sponsored by Institut Paoli-Calmettes. The principal investigator is Marguerite TYRAN, MD at Institut Paoli-Calmettes. The trial plans to enroll 39 participants.