A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
A Prospective, Multicenter, Randomized Controlled Trial of Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
1 other identifier
interventional
255
1 country
1
Brief Summary
A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2020
CompletedStudy Start
First participant enrolled
August 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMarch 26, 2024
March 1, 2024
1.9 years
August 3, 2020
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of tumor down-staging
Tumor down-staging is considered as Stage yp0-II after surgery, and watch-and-wait strategy after complete clinical response (cCR) was allowed.
6-8 months
Secondary Outcomes (10)
Rate of compliance with TNT
6-8 months
3y OS
3years
3y DFS
3years
3y DMFS
3 years
3y LRRFS
3 years
- +5 more secondary outcomes
Study Arms (3)
adjuvant chemotherapy group
ACTIVE COMPARATORconcurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
consolidation chemotherapy group (CNCT group)
EXPERIMENTALconcurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group)
induction chemotherapy group (INCT group)
EXPERIMENTALinduction chemotherapy → concurrent chemoradiotherapy →TME ( INCT group).
Interventions
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
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 6 cycles. 6 courses，3 weeks per course
Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 9 cycles.
Total mesorectal excision
Eligibility Criteria
You may qualify if:
- years old, regardless of gender
- Histologically confirmed rectal adenocarcinoma;
- Up to 12 cm above the anal verge on the basis of rigid rectoscopy.
- MRI of the rectum is acceptable;
- Patients in stage II or III rectal cancer are eligible if any of the following criteria are fulfilled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement.
- ECOG score 0-1 or KPS score ≥80.
You may not qualify if:
- History of malignant tumor in other parts;
- Cannot complete MRI; Allergic to 5-fu drugs; Allergic to platinum drugs;
- During thrombolytic and anticoagulant therapy, the patient has bleeding diathesis or coagulation dysfunction; Or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year;
- History of kidney, urine test found proteinuria or clinical renal function was significantly abnormal;
- History of digestive tract fistula, perforation or severe ulcer;
- Active infection is present; Clinically obvious heart disease; New York heart association (NYHA) of Ⅱ level or congestive heart failure; Unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Scienceslead
- Peking University Cancer Hospital & Institutecollaborator
- Peking Union Medical College Hospitalcollaborator
- Jilin Provincial Tumor Hospitalcollaborator
- Cancer Hospital of Guizhou Provincecollaborator
- Xijing Hospitalcollaborator
Study Sites (1)
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jing Jin, M.D.
Chinese Academy of Medical Sciences and Peking Union Medical College
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor，Radiotherapy Department
Study Record Dates
First Submitted
August 3, 2020
First Posted
September 10, 2020
Study Start
August 15, 2020
Primary Completion
July 12, 2022
Study Completion
June 1, 2025
Last Updated
March 26, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share