Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using MR Guided Linear Accelerator
NCT ID: NCT05338866
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
58 participants
OBSERVATIONAL
2022-01-01
2033-12-31
Brief Summary
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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.
Detailed Description
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The primary endpoint was 3-year progression free survival rate. The secondary end points were 3-year stoma free survival rate, 3-year local regeneration rate, 3-year disease-free survival rate, 3-year distant metastasis rate, 3-year overall survival rate, short term and long-term toxic and side effects, and patients' quality of life scale 1-3 years after treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1. Cohort 2
A total of 6 courses of oxaliplatin plus capecitabine chemotherapy and 2 courses of capecitabine single drug chemotherapy were performed. Concurrent chemoradiotherapy starts at the second cycle.
Cohort 1: For patients with low rectal cancer who refused surgery before the initial diagnosis and treatment, the first stage of radiotherapy used conventional linear accelerated radiotherapy, with doses of GTV 50Gy/25f and CTV 45Gy/25f for 5-6 weeks. Subsequently, the second stage of radiotherapy boost was continued with MR linear accelerator, and the dose was GTV 16\~20Gy/8\~10f for 2 weeks.
Cohort 2: For locally advanced low rectal cancer patients who did not achieve clinical complete remission 6-8 weeks after neoadjuvant radiochemotherapy and refused surgery, radiotherapy was given in the first stage at the doses of GTV 50Gy/25f and CTV 45Gy/25f for 5-6 weeks. In the second stage, MR linear accelerator was used for radiotherapy boosting, and the dose was GTV 30Gy/15f for 3 weeks.
Magnetic resonance guided radiotherapy
Radical radiotherapy boosting for low rectal cancer through magnetic resonance guided radiotherapy linear accelerator.
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.
Interventions
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Magnetic resonance guided radiotherapy
Radical radiotherapy boosting for low rectal cancer through magnetic resonance guided radiotherapy linear accelerator.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. MRI and / or electronic colonoscopy confirmed that the lower edge of the tumor was ≤ 5cm from the anal edge.
3. The AJCC clinical stage was cT1-4NxM0, with or without MRF positive and EMVI positive.
4. MSI gene detection or MMR protein immunohistochemical detection was MSS / PMMR.
5. No obvious signs of intestinal obstruction or intestinal obstruction has been relieved after proximal colostomy.
6. Age: 18 \~ 80 years old.
7. ECOG score: 0-1.
8. Expected life: more than 3 years.
9. Hematology: WBC \> 3 × 109/L; PLT\>80 × 109/L; Hb\>90g/L.
10. Liver function: ALT and AST were less than 2 times of normal value; Bilirubin is less than 1.5 times of normal value.
11. Renal function: creatinine is less than 1.5 times of normal value or creatinine clearance rate (CCR) ≥ 60ml / min.
12. Patient who has not received tumor resection, radiotherapy, chemotherapy, immunotherapy or other anti-tumor treatment.
Exclusion Criteria
2. There are serious medical complications.
3. Uncontrolled infectious diseases, autoimmune diseases and mental diseases.
4. Any unstable condition or situation that may endanger patient safety and compliance.
5. Pregnant or lactating women who are fertile and do not take adequate contraceptive measures.
6. Refuse to sign informed consent.
18 Years
80 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yuan-hong Gao
Professor
Principal Investigators
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Yuanhong Gao, PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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Other Identifiers
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2021-FXY-489
Identifier Type: -
Identifier Source: org_study_id