MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer

Trial Title: MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer

NCT ID: NCT06246344

Condition: Rectal Cancer

Conditions: Official terms:
Rectal Neoplasms

Conditions: Keywords:
neoadjuvant
rectal cancer
chemoradiotherapy

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Radiation
Intervention name: MRI Guided Simultaneous Integrated Boost Radiotherapy
Description: MRI Guided Simultaneous Integrated Boost Radiotherapy
Arm group label: MRIg-LCCRT

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.

Detailed description: MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer

Criteria for eligibility:

Study pop:
locally advanced rectal cancer

Sampling method: Probability Sample
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Radiation Oncology, Shandong Cancer Hospital and Institute

Address:
City: Jinan
Zip: 0531
Country: China

Status: Recruiting

Contact:
Last name: Jinbo Yue, doctor

Phone: 0531-67626442
Email: yuejinbo@hotmail.com

Start date: December 1, 2023

Completion date: December 1, 2025

Lead sponsor:
Agency: Shandong Cancer Hospital and Institute
Agency class: Other

Source: Shandong Cancer Hospital and Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06246344