NCT03961776Recruiting
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
Source: ClinicalTrials.gov · Last updated 6 May 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 39 (estimated)
- First submitted
- 20 May 2019
- Start date
- 8 Jun 2020
- Primary completion date
- May 2022
- Lead sponsor
- Institut Paoli-Calmettes
- Diseases
- Colorectal cancer
- NCT number
- NCT03961776
What you commit to
- Study type: Observational
- Planned participants: 39
- From 8 Jun 2020 to the primary completion date, May 2022
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exclusive radiation therapy.
- Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.
- Participation in a protocol with concurrent treatment.
Other illness
- Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU / capecitabine and / or its excipients.
Lab values
- Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance \<30 ml / min),
Age
- Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent.
Other
- 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).
- Other associated neo-adjuvant treatment.
- Pregnant or likely to be pregnant (without effective contraception) or breastfeeding
- Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.
Who the study is looking for
- 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.
- For women of childbearing age, effective contraception must also be agreed for the duration of treatment.
- Affiliation to a social security regimen, or beneficiary of such a regimen.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| University of California Los Angeles (UCLA). Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.