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Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using MR Guided Linear Accelerator

NCT05338866 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2023-11-22

No results posted yet for this study

Summary

The incidence rate of colorectal cancer is third in male tumors and second in female tumors. The newly diagnosed incidence of colorectal cancer is no less than 100 thousand in China, which poses a great threat to people's health and a heavy burden of public health. Preoperative neoadjuvant radiotherapy and chemotherapy combined with radical surgery is recommended for locally advanced rectal cancer. Low rectal cancer accounts for about one third of all rectal cancer cases. Due to the particularity of its location，surgical complications and postoperative patients need permanent colostomy (artificial anus) to solve the defecation problems, which has a serious impact on the patients' work and life. How to improve the quality of life of patients without reducing the survival rate has become an important topic in the treatment of low rectal cancer. Previous studies have shown that the prognosis of patients with pathological complete remission (pCR) after neoadjuvant chemoradiotherapy for rectal cancer is optimistic. The clinical efficacy of "observation and waiting" is good. The results of small sample exploratory clinical studies of radical radiotherapy and chemotherapy for low rectal cancer are satisfactory, and MR-linear accelerator can be used for precision radiotherapy for colorectal cancer.

This study is aimed to explore the efficacy and safety of radical radiotherapy boost for low rectal cancer by using magnetic resonance guided radiotherapy system, and further evaluate the impact of boost on the quality of life of patients.

Conditions

Interventions

RADIATION

Magnetic resonance guided radiotherapy

Radical radiotherapy boosting for low rectal cancer through magnetic resonance guided radiotherapy linear accelerator.

DRUG

Chemotherapy

For patients with AJCC stage II and III and age \< 72 years old, Capox ×6→capecitabine×2. Detailed usage: Oxaliplatin 130mg/m2 (reduced to 100mg/m2 during concurrent chemoradiotherapy), intravenous administration, d1. Capecitabine 1000mg / m2, twice a day, d1-14. Repeated every 3 weeks. For patients aged ≥ 72 years, or the competent physician judges that the patients cannot tolerate dual drug combined chemotherapy, capecitabine ×8 courses. For patients with AJCC stage I, capecitabine ×4 courses.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yuanhong Gao, PhD · Sun Yat-sen University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2030-12-31
Completion
2033-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05338866 on ClinicalTrials.gov