Clinical trial · Observational
MRI for Selection of Complete Responders After Chemoradiation for Locally Advanced Rectal Cancer
MRI for Response Evaluation After Chemoradiation for Locally Advanced Rectal Cancer
NCT04790227CI-TRIAL-00056269unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of our study is to evaluate the accuracy of MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Rectum | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- MRI for selection of chemoradiation response evaluation for cancer rectum
- timeFrame
- Baseline
- description
- The purpose of our study is to evaluate the accuracy of MRI for response evaluation after chemoradiation for locally advanced rectal cancer . Primary outcome includes Tumor site, size, volume, extension, T2, DWI signal intensity. Secondary outcome after chemo-radiotherapy in T2, DWI signal intensity changes
- measure
- Secondary outcome after chemo-radiotherapy
- timeFrame
- 2 months
- description
- in T2, DWI signal intensity changes T2, DWI signal intensity changes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \>18 years old with locally advanced rectal adenocarcinoma (T3c-T4 N any, CRM+ M0) treated with neoadjuvant chemoradiotherapy * Baseline and post treatment MRI scans required for each patient; * Clinical assessment including digital rectal examination, and endoscopy are needed for each patient Exclusion Criteria: * \- Patient who is not fit for preoperative CRT
References
Publications (8)
- BACKGROUNDMaas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6. PMID 20692872
- BACKGROUNDHabr-Gama A, Perez RO, Proscurshim I, Campos FG, Nadalin W, Kiss D, Gama-Rodrigues J. Patterns of failure and survival for nonoperative treatment of stage c0 distal rectal cancer following neoadjuvant chemoradiation therapy. J Gastrointest Surg. 2006 Dec;10(10):1319-28; discussion 1328-9. doi: 10.1016/j.gassur.2006.09.005. PMID 17175450
- BACKGROUNDOn J, Aly EH. 'Watch and wait' in rectal cancer: summary of the current evidence. Int J Colorectal Dis. 2018 Sep;33(9):1159-1168. doi: 10.1007/s00384-018-3116-5. Epub 2018 Jul 5. PMID 29978363
- BACKGROUNDPatel UB, Taylor F, Blomqvist L, George C, Evans H, Tekkis P, Quirke P, Sebag-Montefiore D, Moran B, Heald R, Guthrie A, Bees N, Swift I, Pennert K, Brown G. Magnetic resonance imaging-detected tumor response for locally advanced rectal cancer predicts survival outcomes: MERCURY experience. J Clin Oncol. 2011 Oct 1;29(28):3753-60. doi: 10.1200/JCO.2011.34.9068. Epub 2011 Aug 29. PMID 21876084
- BACKGROUNDFayaz MS, Demian GA, Fathallah WM, Eissa HE, El-Sherify MS, Abozlouf S, George T, Samir SM. Significance of Magnetic Resonance Imaging-Assessed Tumor Response for Locally Advanced Rectal Cancer Treated With Preoperative Long-Course Chemoradiation. J Glob Oncol. 2016 Feb 10;2(4):216-221. doi: 10.1200/JGO.2015.001479. eCollection 2016 Aug. PMID 28717704
- BACKGROUNDKim SH, Lee JM, Hong SH, Kim GH, Lee JY, Han JK, Choi BI. Locally advanced rectal cancer: added value of diffusion-weighted MR imaging in the evaluation of tumor response to neoadjuvant chemo- and radiation therapy. Radiology. 2009 Oct;253(1):116-25. doi: 10.1148/radiol.2532090027.