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Rectal Neoplasms

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Capecitabine

Oxaliplatin

Radiotherapy: The pelvic lymph node drainage area (CTV) is targeted with a dose of 45-50 Gy delivered in 25 fractions.

Concurrent Chemotherapy: During radiotherapy, concurrent administration of capecitabine at a dose of 825 mg/m2, twice daily.

Consolidation Chemotherapy Phase: On Day 1, two cycles of the CAPEOX regimen are administered (capecitabine 1.0 g/m2 po bid d1-14 + oxaliplatin 130 mg/m2, q3w). Initiated 7-10 days after completion of LCCRT.

Surgical Phase: Commencing on Day 1, the patient undergoes Total Mesorectal Excision (TME) following consolidation chemotherapy.

Radiotherapy (SIB): Targeting the rectal tumor (GTVp) and regional metastatic lymph nodes (GTVn) with a dose of 60-65 Gy delivered in 25 fractions; the pelvic lymph node drainage area (CTV) receives a dose of 45-50 Gy delivered in 25 fractions.

Concurrent Chemotherapy: During radiotherapy, concurrent administration of capecitabine at a dose of 825 mg/m2, twice daily.

Consolidation Chemotherapy Phase: On Day 1, two cycles of the CAPEOX regimen are administered (capecitabine 1.0 g/m2 po bid d1-14 + oxaliplatin 130 mg/m2, q3w). Initiated 7-10 days after completion of LCCRT.

Surgical Phase: Commencing on Day 1, the patient undergoes Total Mesorectal Excision (TME) following consolidation chemotherapy.

MRI Guided Simultaneous Integrated Boost Radiotherapy

lei xu, dorctor

Jinbo Yue, doctor

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.

MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer

Collecting surgical pathology specimens, fecal samples, and blood from patients.

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

primary tumor achieved pathological complete response

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.

primary tumor achieved clinical complete response

The proportion of patients from the commencement of self-diagnosis to the time of death for any reason within 3 years

The proportion of patients from the commencement of self-diagnosis to the time of death for any reason within 5 years

The proportion of patients from the initiation of surgery to tumor recurrence or death within 3 years

The proportion of patients from the initiation of surgery to tumor recurrence or death within 5 years

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Higher scores mean a worse outcome.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer	NCT06246344	Rectal Cancer	MRI Guided Simu...	18 Years - 75 Years	Shandong Cancer Hospital and Institute
MRI Guided SIB Radiotherapy in Neoadjuvant Therapy for Advanced Rectal Cancer	NCT06246344	Rectal Cancer	MRI Guided Simu...	18 Years - 75 Years	Shandong Cancer Hospital and Institute

Spots Global Cancer Trial Database for mri guided simultaneous integrated boost radiotherapy