MRI for Selection of Complete Responders After Chemoradiation for Locally Advanced Rectal Cancer
MRI for Response Evaluation After Chemoradiation for Locally Advanced Rectal Cancer
1 other identifier
observational
50
1 country
2
Brief Summary
The purpose of our study is to evaluate the accuracy of MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2022
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedFebruary 1, 2022
January 1, 2022
5 months
May 4, 2020
January 18, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
MRI for selection of chemoradiation response evaluation for cancer rectum
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
Baseline
Secondary outcome after chemo-radiotherapy
in T2, DWI signal intensity changes T2, DWI signal intensity changes
2 months
Interventions
MRI
Eligibility Criteria
18 years old with locally advanced rectal adenocarcinoma (T3c-T4 N any, CRM+ M0) treated with neoadjuvant chemoradiotherapy
You may qualify if:
- 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
You may not qualify if:
- \- Patient who is not fit for preoperative CRT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Assuit University
Asyut, Egypt
Assuit University
Asyut, Egypt
Related Publications (8)
Maas 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: 20692872BACKGROUNDHabr-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: 17175450BACKGROUNDOn 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: 29978363BACKGROUNDPatel 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: 21876084BACKGROUNDFayaz 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: 28717704BACKGROUNDKim 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.
PMID: 19789256BACKGROUNDSun YS, Zhang XP, Tang L, Ji JF, Gu J, Cai Y, Zhang XY. Locally advanced rectal carcinoma treated with preoperative chemotherapy and radiation therapy: preliminary analysis of diffusion-weighted MR imaging for early detection of tumor histopathologic downstaging. Radiology. 2010 Jan;254(1):170-8. doi: 10.1148/radiol.2541082230. Epub 2009 Dec 17.
PMID: 20019139BACKGROUNDKremser C, Judmaier W, Hein P, Griebel J, Lukas P, de Vries A. Preliminary results on the influence of chemoradiation on apparent diffusion coefficients of primary rectal carcinoma measured by magnetic resonance imaging. Strahlenther Onkol. 2003 Sep;179(9):641-9. doi: 10.1007/s00066-003-1045-9.
PMID: 14628131BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shymaa Abdallah, Lecturer
Assiut University
- STUDY CHAIR
Hossam Eldin Galal, Proffesor
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
May 4, 2020
First Posted
March 10, 2021
Study Start
January 1, 2022
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
February 1, 2022
Record last verified: 2022-01