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MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer - Trial NCT06246344

Access comprehensive clinical trial information for NCT06246344 through Pure Global AI's free database. This phase not specified trial is sponsored by Shandong Cancer Hospital and Institute and is currently Recruiting. The study focuses on Rectal Cancer. Target enrollment is 128 participants.

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NCT06246344
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radiation
Trial Details
ClinicalTrials.gov โ€ข NCT06246344
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MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer
Efficacy of MRI Guided Simultaneous Integrated Boost Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer: a Randomized, Controlled, Phase III Clinical Trial

Study Focus

Rectal Cancer

MRI Guided Simultaneous Integrated Boost Radiotherapy

Observational

radiation

Sponsor & Location

Shandong Cancer Hospital and Institute

Jinan, China

Timeline & Enrollment

N/A

Dec 01, 2023

Dec 01, 2025

128 participants

Primary Outcome

pCR,surgical difficulty

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.

ICD-10 Classifications

Malignant neoplasm of rectum
Carcinoma in situ: Rectum
Benign neoplasm: Rectum
Secondary malignant neoplasm of large intestine and rectum
Carcinoma in situ: Rectosigmoid junction

Data Source

ClinicalTrials.gov

NCT06246344

Non-Device Trial