MRI for Selection of Complete Responders After Chemoradiation for Locally Advanced Rectal Cancer

NCT ID: NCT04790227

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-07-31

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 .

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

MRI

MRI

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Yehia Hefz Abd El.wanis

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shymaa Abdallah, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Hossam Eldin Galal, Proffesor

Role: STUDY_CHAIR

Assiut University

Locations

Assuit University

Asyut, , Egypt

Assuit University

Asyut, , Egypt

Countries

Egypt

Central Contacts

Ahmed Abdel-wanis, Resident

Role: CONTACT

hamadany07@Gmail.com

+201064478336

Mohamed Elbaroudy, Lecturer

Role: CONTACT

+20106220029

Facility Contacts

Ahmed Abd El-wanis, Resident

Role: primary

hamadany07@gmail.com

+201064478336

Ahmed Abd Elwanis, Resident

Role: primary

hamadany07@gmail.com

+201064478336

References

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.

Reference Type: BACKGROUND

PMID: 20692872 (View on PubMed)

Habr-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.

Reference Type: BACKGROUND

PMID: 17175450 (View on PubMed)

On 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.

Reference Type: BACKGROUND

PMID: 29978363 (View on PubMed)

Patel 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.

Reference Type: BACKGROUND

PMID: 21876084 (View on PubMed)

Fayaz 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.

Reference Type: BACKGROUND

PMID: 28717704 (View on PubMed)

Kim 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.

Reference Type: BACKGROUND

PMID: 19789256 (View on PubMed)

Sun 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.

Reference Type: BACKGROUND

PMID: 20019139 (View on PubMed)

Kremser 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.

Reference Type: BACKGROUND

PMID: 14628131 (View on PubMed)

Other Identifiers

MRI Rectum

Identifier Type: -

Identifier Source: org_study_id