MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Efficacy of MRI Guided Simultaneous Integrated Boost Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer: a Randomized, Controlled, Phase III Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246344
• Other study ID #: SDZLEC2023-390-01
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Shandong Cancer Hospital and Institute
• Contact: lei xu, dorctor
• Phone: +86053167626442
• Email: Len.Xu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Colorectal cancer has an annual incidence surpassing 700,000 cases globally, ranking as the fourth most prevalent cancer with the second-highest mortality rate. Rectal cancer accounts for approximately one-third of newly diagnosed colorectal cancer cases. Stages II (cT3-4/N0) and III (cT1-4/N1-3) rectal cancer are commonly classified as Locally Advanced Rectal Cancer (LARC), characterized by a high risk of local recurrence post-surgery. Neoadjuvant chemoradiotherapy (CRT) combined with Total Mesorectal Excision Surgery (TME) has reduced the 5-year local recurrence rate in LARC from 25% to 5%-10%. Currently, neoadjuvant CRT+TME+postoperative adjuvant chemotherapy effectively controls local recurrence in LARC. However, it is associated with low Pathological Complete Regression (pCR) rates, suboptimal sphincter preservation, increased distant metastasis, heterogeneous adherence to adjuvant chemotherapy, and limited long-term survival benefits. Further optimization of neoadjuvant treatment strategies holds promise for promoting tumor regression and improving prognosis. In neoadjuvant therapy, the extent of rectal tumor regression is highly dependent on radiotherapy, with higher radiation doses correlating with increased rates of pathological regression. This study aims to investigate the role of MRI-guided radiotherapy with a simultaneous integrated boost in enhancing tumor pCR in neoadjuvant treatment for locally advanced rectal cancer.

Description:

MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histopathologically confirmed rectal adenocarcinoma.
• Tumor located =10cm from the anal verge.
• Age =18 years.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.
• Primary treatment-naive tumor confirmed by endorectal ultrasound (ERUS) or -
• Magnetic resonance imaging (MRI) as cT3-4/N+ according to the 8th edition of AJCC staging.
• Ability to provide tissue and blood samples for translational research.
• Anticipated survival of =6 months.
• Normal major organ function (within 14 days prior to enrollment) and suitability for receiving chemoradiotherapy.

Exclusion Criteria:

• History of prior chemotherapy, radiotherapy, or surgical treatment for rectal cancer, including transanal tumor resection.
• Locally recurrent rectal cancer.
• History of familial adenomatous polyposis.
• Active Crohn's disease or ulcerative colitis.
• Allergy or hypersensitivity history to 5-fluorouracil (fluorouracil) and/or oxaliplatin.
• History of difficulty or inability to take or absorb oral medications.
• Diagnosis of malignancy other than rectal cancer within the past 5 years (excluding completely cured basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma treated with radical resection).
• Confirmed distant metastasis, i.e., cM1, through imaging or biopsy.
• History of pelvic radiotherapy.
• Pregnant or lactating women.
• Presence of any severe or uncontrollable systemic illness.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• MRI Guided Simultaneous Integrated Boost Radiotherapy
MRI Guided Simultaneous Integrated Boost Radiotherapy

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

References & Publications (9)

Camma C, Giunta M, Fiorica F, Pagliaro L, Craxi A, Cottone M. Preoperative radiotherapy for resectable rectal cancer: A meta-analysis. JAMA. 2000 Aug 23-30;284(8):1008-15. doi: 10.1001/jama.284.8.1008. — View Citation

Fernandez-Martos C, Garcia-Albeniz X, Pericay C, Maurel J, Aparicio J, Montagut C, Safont MJ, Salud A, Vera R, Massuti B, Escudero P, Alonso V, Bosch C, Martin M, Minsky BD. Chemoradiation, surgery and adjuvant chemotherapy versus induction chemotherapy f — View Citation

Fokas E, Schlenska-Lange A, Polat B, Klautke G, Grabenbauer GG, Fietkau R, Kuhnt T, Staib L, Brunner T, Grosu AL, Kirste S, Jacobasch L, Allgauer M, Flentje M, Germer CT, Grutzmann R, Hildebrandt G, Schwarzbach M, Bechstein WO, Sulberg H, Friede T, Gaedck — View Citation

Garcia-Aguilar J, Chow OS, Smith DD, Marcet JE, Cataldo PA, Varma MG, Kumar AS, Oommen S, Coutsoftides T, Hunt SR, Stamos MJ, Ternent CA, Herzig DO, Fichera A, Polite BN, Dietz DW, Patil S, Avila K; Timing of Rectal Cancer Response to Chemoradiation Conso — View Citation

Gollins S, Sebag-Montefiore D. Neoadjuvant Treatment Strategies for Locally Advanced Rectal Cancer. Clin Oncol (R Coll Radiol). 2016 Feb;28(2):146-151. doi: 10.1016/j.clon.2015.11.003. Epub 2015 Nov 29. — View Citation

Lefevre JH, Mineur L, Kotti S, Rullier E, Rouanet P, de Chaisemartin C, Meunier B, Mehrdad J, Cotte E, Desrame J, Karoui M, Benoist S, Kirzin S, Berger A, Panis Y, Piessen G, Saudemont A, Prudhomme M, Peschaud F, Dubois A, Loriau J, Tuech JJ, Meurette G, — View Citation

Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, Ackland SP, Schache D, McClure B, McLachlan SA, McKendrick J, Leong T, Hartopeanu C, Zalcberg J, Mackay J. Randomized trial of short-course radiotherapy versus long-course chemoradiation — View Citation

Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. Erratum In: CA Cancer J Clin. 2021 Jul;71(4):359. — View Citation

van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	primary tumor achieved pathological complete response	1 year
Primary	surgical difficulty	The difficulty score of a surgery is calculated through a comprehensive assessment of the following indicators: surgical blood loss, surgical blood loss, pelvic fibrosis, pelvic fibrosis, degree of edema, number of anastomotic fistulas, and number of urinary dysfunctions.	2 years
Secondary	cCR	primary tumor achieved clinical complete response	2 years
Secondary	3-year overal survival rate	The proportion of patients from the commencement of self-diagnosis to the time of death for any reason within 3 years	3 years
Secondary	5-year overal survival rate	The proportion of patients from the commencement of self-diagnosis to the time of death for any reason within 5 years	5 years
Secondary	3-year disease free suvival rate	The proportion of patients from the initiation of surgery to tumor recurrence or death within 3 years	3 years
Secondary	5-year disease free suvival rate	The proportion of patients from the initiation of surgery to tumor recurrence or death within 5 years	5 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Higher scores mean a worse outcome.	3 years
Secondary	The Late Effects Normal Tissue/Subjective Objective Management Analytic (LENT/SOMA) system	The Late Effects Normal Tissue/Subjective Objective Management Analytic (LENT/SOMA) system for grading of side effects after radiotherapy was proposed, mainly including tenesmus, mucosal loss, sphincter control, stool frequency, pain, bleeding, ulceration, stricture, etc. Higher scores mean a worse outcome.	3 years
Secondary	QLQ-C30	The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. Higher scores mean a worse outcome.	3 year
Secondary	QLQ-CR29	The QLQ-CR29 was created with six hypothesised scales (micturition, pain, faecal incontinence, defaecation problems, anxiety and body image) and 11 single items. Higher scores mean a worse outcome.	3 years