Back to resultsAdjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients
Primary Purpose
Colorectal Cancer, Chemotherapy Effect
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
FOLFOX chemotherapy regimens
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: Both sexes, aged 18-75 years; Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery; ASA grade < IV and/or ECOG performance status score ≤ 2 points; Fully understand and voluntarily sign the informed consent form for this study. Exclusion Criteria: A history of other malignant tumors; Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy; Patients allergic to any component in the study; Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases; Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe abnormalities in laboratory tests; Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.; Patients with a history of severe mental illness; Pregnant or lactating women; Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.
Sites / Locations
- The Sixth Affiliate Hospital of Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Combining targeted therapy group
Single adjuvant chemotherapy group
Arm Description
Adjuvant chemotherapy with targeted therapy
Adjuvant chemotherapy alone
Outcomes
Primary Outcome Measures
3-year disease-free survival
disease-free survival (DFS) is defined as the time from the date of surgery for colorectal cancer to the occurrence of tumor recurrence or metastasis, or death from any cause.
5-year disease-free survival
median of disease-free survival
Secondary Outcome Measures
3-year overall survival
Overall survival (OS) is defined as the time from the date of randomization to the date of death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.
5-year overall survival
Complications
When evaluating the safety and tolerability of adjuvant therapy, researchers typically assess adverse events (AEs) based on their incidence and severity, and then grade them according to the NCI CTCAE version 5.0. NCI CTCAE 5.0 categorizes AEs into 5 grades based on severity, including grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death).
Full Information
NCT ID
NCT05797467
First Posted
March 20, 2023
Last Updated
May 22, 2023
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05797467
Brief Title
Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients
Official Title
Adjuvant Chemotherapy Combined With Targeted Therapy Versus Adjuvant Chemotherapy Alone in the Treatment of Stage T3-4N2 Colorectal Cancer:A Multicenter, Randomized, Phase III Clinical Trail
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2030 (Anticipated)
Study Completion Date
April 1, 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this clinical trial] is to compare in resectable stage T3-4N2 colorectal cancer. The main question it aims to answer is: whether the use of targeted therapy in combination with adjuvant chemotherapy is associated with improved disease-free survival (DFS) compared to adjuvant chemotherapy alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Chemotherapy Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combining targeted therapy group
Arm Type
Experimental
Arm Description
Adjuvant chemotherapy with targeted therapy
Arm Title
Single adjuvant chemotherapy group
Arm Type
Sham Comparator
Arm Description
Adjuvant chemotherapy alone
Intervention Type
Drug
Intervention Name(s)
FOLFOX chemotherapy regimens
Other Intervention Name(s)
CapeOx regimens
Intervention Description
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Cetuximab
Intervention Description
Targeted therapy regimens are recommended based on gene testing results. For colorectal cancer patients with KRAS/NRAS/BRAF gene mutations, it is recommended to use Bevacizumab in combination with chemotherapy. For right-sided colon cancer patients with wild-type KRAS/NRAS/BRAF genes, it is recommended to use Bevacizumab. For left-sided colon and rectal cancer patients with wild-type KRAS/NRAS/BRAF genes, it is recommended to use Cetuximab.When using targeted therapy in combination with chemotherapy, the treatment course should be synchronized with chemotherapy (Bev 5mg/kg iv d1 or Cet 500mg/m2 iv d1).
Primary Outcome Measure Information:
Title
3-year disease-free survival
Description
disease-free survival (DFS) is defined as the time from the date of surgery for colorectal cancer to the occurrence of tumor recurrence or metastasis, or death from any cause.
Time Frame
3 years after operation.
Title
5-year disease-free survival
Time Frame
5 years after operation.
Title
median of disease-free survival
Time Frame
5 years after operation.
Secondary Outcome Measure Information:
Title
3-year overall survival
Description
Overall survival (OS) is defined as the time from the date of randomization to the date of death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.
Time Frame
3 years after recruited.
Title
5-year overall survival
Time Frame
5 years after recruited.
Title
Complications
Description
When evaluating the safety and tolerability of adjuvant therapy, researchers typically assess adverse events (AEs) based on their incidence and severity, and then grade them according to the NCI CTCAE version 5.0. NCI CTCAE 5.0 categorizes AEs into 5 grades based on severity, including grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death).
Time Frame
5 years after recruited.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Both sexes, aged 18-75 years;
Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;
ASA grade < IV and/or ECOG performance status score ≤ 2 points;
Fully understand and voluntarily sign the informed consent form for this study.
Exclusion Criteria:
A history of other malignant tumors;
Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;
Patients allergic to any component in the study;
Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases;
Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe abnormalities in laboratory tests;
Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
Patients with a history of severe mental illness;
Pregnant or lactating women;
Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.
Facility Information:
Facility Name
The Sixth Affiliate Hospital of Sun Yat-Sen University
City
GuangZhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxin Luo, PhD,MD
Phone
86-13826190263
Email
luoyx25@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yaoyi Huang, BS
Phone
86-15986423743
Email
huangyy355@mail2.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients
We'll reach out to this number within 24 hrs