Cancer, RectumNCT04790227
MRI for Selection of Complete Responders After Chemoradiation for Locally Advanced Rectal Cancer
An observational study of Cancer, Rectum, run by Assiut University at 2 sites in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer, Rectum
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2022to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: 18 years old with locally advanced rectal adenocarcinoma (T3c-T4 N any, CRM+ M0) treated with neoadjuvant chemoradiotherapy
Who may be able to join
- 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
Who cannot join
- - Patient who is not fit for preoperative CRT
Trial locations and contacts
2 sites in 1 country.
Mohamed Elbaroudy, Lecturer contact
Egypt2 sites
Assuit University
Asyut
Ahmed Abd El-wanis, Resident, +201064478336, hamadany07@gmail.com
Assuit University
Asyut
Ahmed Abd Elwanis, Resident, +201064478336, hamadany07@gmail.com
About this study
Official title: MRI for Response Evaluation After Chemoradiation for Locally Advanced Rectal Cancer
The purpose of our study is to evaluate the accuracy of MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer .
Read the detailed description
The current standard of care for patients with T3 or T4 and/or node-positive rectal adenocarcinoma is to offer preoperative concomitant chemoradiotherapy(CRT) followed by total mesorectal excision (TME). 1 In 10-24% of patients, no residual tumor is found at histology after surgery.2 These complete responders are known to have a very good prognosis, in terms of overall and disease-free survival.2 A complete response also raises the hotly debated question of whether surgery is still necessary for these patients, especially because total mesorectal excision (TME) may have associated morbidity and even mortality and has the potential risk of a permanent colostomy.
Recently, a more conservative treatment is advocated in patients who show a good or complete response to neoadjuvant treatment. In 2006, Habr-Gama et al. Presented the long-term results of a prospective trial that investigated a "wait-and-see" policy in a carefully selected group of patients with clinical and radiological evidence of a complete response after neoadjuvant CRT. Results at 5-year follow-up were favorable for the nonsurgical group, with an overall and disease-free survival of 93% and 85%, respectively 3.
Recently, A watch and wait policy avoids the morbidity associated with radical surgery and preserves oncologic outcomes. It could be considered a therapeutic option in patients with locally advanced rectal cancer following chemoradiotherapy with a complete clinical response.4 To safely omit surgery, it is essential to select accurately the right candidates, i.e., the true complete responders. This selection is mainly performed using digital examination, endoscopy, and biopsy, but these methods are not infallible.
High-resolution magnetic resonance imaging (MRI) has been used to assess tumor response before surgical resection. By applying the principals of histopathologic TRG and by exploiting the characteristic MRI low-signal-intensity appearances of fibrosis, it has been possible to develop a similar MRI-based TRG system. The MRI-assessed TRG (mrTRG) was found to be an independent prognostic factor for overall survival (OS) and DFS.5 Complete pathologic response (pCR) after CRT has led to the proposal of a nonoperative approach as an alternate treatment for highly selected patients with a complete clinical response (CR). Habr-Gama et al reported findings from 99 patients with a clinical CR who were treated with observation alone. The 5-year OS and DFS rates were 93% and 85%, respectively.6 In a recent study, MRI-assessed complete tumor response was strongly correlated with pathologic complete response and, therefore, can be used as a surrogate marker to predict absence of viable tumor cells.7 Recently, Diffusion-weighted MRI (DWI) could be useful for response evaluation after chemoradiation treatment (8-10) In 2009, Kim et al. showed in a study of 40 patients that DWI in addition to standard MRI significantly improved the performance of radiologists to select complete responders compared with standard MRI only
- Conditions
- Cancer, Rectum
- Being tested
- MRI
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcome after chemo-radiotherapy
in T2, DWI signal intensity changes T2, DWI signal intensity changes
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study startJan 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cancer, RectumStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Yehia Hefz Abd El.wanis, Assiut University
- Investigators
- Shymaa Abdallah, Lecturer, Study director, Assiut UniversityHossam Eldin Galal, Proffesor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790227
- Sponsor's protocol ID
- MRI Rectum
- Status last verified
- Jan 2022
- First submitted
- 4 May 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20692872Habr-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.
PubMed 17175450On 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.
PubMed 29978363Patel 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.
PubMed 21876084Fayaz 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.
PubMed 28717704Kim 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.
PubMed 19789256Sun 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.
PubMed 20019139Kremser 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.
PubMed 14628131
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI for Response Evaluation After Chemoradiation for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04790227
- Acronym / sponsor ID
- MRI Rectum
- Conditions
- Cancer, Rectum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of our study is to evaluate the accuracy of MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer .
Detailed description
The current standard of care for patients with T3 or T4 and/or node-positive rectal adenocarcinoma is to offer preoperative concomitant chemoradiotherapy(CRT) followed by total mesorectal excision (TME). 1 In 10-24% of patients, no residual tumor is found at histology after surgery.2 These complete responders are known to have a very good prognosis, in terms of overall and disease-free survival.2 A complete response also raises the hotly debated question of whether surgery is still necessary for these patients, especially because total mesorectal excision (TME) may have associated morbidity and even mortality and has the potential risk of a permanent colostomy.
Recently, a more conservative treatment is advocated in patients who show a good or complete response to neoadjuvant treatment. In 2006, Habr-Gama et al. Presented the long-term results of a prospective trial that investigated a "wait-and-see" policy in a carefully selected group of patients with clinical and radiological evidence of a complete response after neoadjuvant CRT. Results at 5-year follow-up were favorable for the nonsurgical group, with an overall and disease-free survival of 93% and 85%, respectively 3.
Recently, A watch and wait policy avoids the morbidity associated with radical surgery and preserves oncologic outcomes. It could be considered a therapeutic option in patients with locally advanced rectal cancer following chemoradiotherapy with a complete clinical response.4 To safely omit surgery, it is essential to select accurately the right candidates, i.e., the true complete responders. This selection is mainly performed using digital examination, endoscopy, and biopsy, but these methods are not infallible.
High-resolution magnetic resonance imaging (MRI) has been used to assess tumor response before surgical resection. By applying the principals of histopathologic TRG and by exploiting the characteristic MRI low-signal-intensity appearances of fibrosis, it has been possible to develop a similar MRI-based TRG system. The MRI-assessed TRG (mrTRG) was found to be an independent prognostic factor for overall survival (OS) and DFS.5 Complete pathologic response (pCR) after CRT has led to the proposal of a nonoperative approach as an alternate treatment for highly selected patients with a complete clinical response (CR). Habr-Gama et al reported findings from 99 patients with a clinical CR who were treated with observation alone. The 5-year OS and DFS rates were 93% and 85%, respectively.6 In a recent study, MRI-assessed complete tumor response was strongly correlated with pathologic complete response and, therefore, can be used as a surrogate marker to predict absence of viable tumor cells.7 Recently, Diffusion-weighted MRI (DWI) could be useful for response evaluation after chemoradiation treatment (8-10) In 2009, Kim et al. showed in a study of 40 patients that DWI in addition to standard MRI significantly improved the performance of radiologists to select complete responders compared with standard MRI only
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 18 years old with locally advanced rectal adenocarcinoma (T3c-T4 N any, CRM+ M0) treated with neoadjuvant chemoradiotherapy
Key inclusion criteria (3 listed)
- Patients >18 years old with locally advanced rectal adenocarcinoma (T3c-T4 N any, CRM+ M0) treated with neoadjuvant chemoradiotherapy
Key exclusion criteria (1 listed)
- - Patient who is not fit for preoperative CRT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI | Device | – |
Primary outcome
MRI for selection of chemoradiation response evaluation for cancer rectum
Time frame: Baseline
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
Secondary outcome after chemo-radiotherapy
Time frame: 2 months
in T2, DWI signal intensity changes T2, DWI signal intensity changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Background: PubMed 20692872Maas 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.
- Background: PubMed 17175450Habr-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.
- Background: PubMed 29978363On 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.
- Background: PubMed 21876084Patel 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.
- Background: PubMed 28717704Fayaz 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.
- Background: PubMed 19789256Kim 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.
- Background: PubMed 20019139Sun 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.
- Background: PubMed 14628131Kremser 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Elbaroudy, Lecturer contact
Shymaa Abdallah, Lecturer study director
Assiut University
Hossam Eldin Galal, Proffesor study chair
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, Rectum, run by Assiut University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdel-wanis, Resident (+201064478336, hamadany07@Gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI for selection of chemoradiation response evaluation for cancer rectum (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04790227, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.