A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
NCT ID: NCT04664504
Last Updated: 2021-06-08
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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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2020-12-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group CRT
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
Concurrent Chemoradiotherapy Radiotherapy
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.
Adjuvant chemotherapy
2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses\*3 weeks per course
TME
Total mesorectal excision
Group SCRT
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Short-course Radiotherapy
25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Consolidation chemotherapy
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses\*3 weeks per course.
TME
Total mesorectal excision
Group es-SCRT
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Local dose increase of Short-course Radiotherapy
25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Consolidation chemotherapy
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses\*3 weeks per course.
TME
Total mesorectal excision
Interventions
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Concurrent Chemoradiotherapy Radiotherapy
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.
Short-course Radiotherapy
25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Local dose increase of Short-course Radiotherapy
25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Consolidation chemotherapy
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses\*3 weeks per course.
Adjuvant chemotherapy
2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses\*3 weeks per course
TME
Total mesorectal excision
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
3. The age is 18-75 years old, no gender limit
3\) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1
Exclusion Criteria
2. They were allergic to 5-FU, platinum, etc;
3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;
4. After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
5. History of gastrointestinal fistula, perforation or severe ulcer;
6. At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
18 Years
75 Years
ALL
No
Sponsors
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Jing Jin, M.D.
UNKNOWN
Responsible Party
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Jing Jin, M.D.
Clinical Professor, Radiotherapy Department
Principal Investigators
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Yuan Tang, M.D.
Role: STUDY_DIRECTOR
Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3332019055
Identifier Type: -
Identifier Source: org_study_id
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