Back to resultsctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
Primary Purpose
Colorectal Cancer, Liver Metastases, Circulating Tumor Cell
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Colorectal cancer resection combined with liver metastasis resection.
FOLFOX chemotherapy regimen
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Liver Metastases, Circulating Tumor DNA
Eligibility Criteria
Inclusion Criteria: Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy; Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects); Patients with negative ctDNA after surgery; ASA grade <IV and/or ECOG performance status score ≤ 2; Have sufficient understanding of the study and voluntarily sign an informed consent form. Exclusion Criteria: Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.; Patients with a history of other malignancies; Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy; Patients who are allergic to any component in the study; Patients who have received other tumor-related investigational drug therapy; Patients with severe uncontrolled recurrent infections or other serious uncontrolled 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 that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests; Patients with a history of severe mental illness; Pregnant or lactating women; Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.
Sites / Locations
- The Sixth Affiliate Hospital of Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Watching and waiting group
Adjuvant chemotherapy group
Arm Description
Watch and Wait strategy is one of the treatment strategies of advanced rectal cancer, which recommends no immediate surgery with close surveillance.
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
Outcomes
Primary Outcome Measures
3-year progression-free survival
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
5-year progression-free survival
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Secondary Outcome Measures
3-year overall survival
Overall survival is defined as the time from randomization to 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.
3-year overall survival
Overall survival is defined as the time from randomization to 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.
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
NCT05815082
First Posted
March 20, 2023
Last Updated
April 14, 2023
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05815082
Brief Title
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
Official Title
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
February 20, 2031 (Anticipated)
Study Completion Date
February 20, 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 colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Metastases, Circulating Tumor Cell, Chemotherapy Effect
Keywords
Colorectal Cancer, Liver Metastases, Circulating Tumor DNA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
490 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Watching and waiting group
Arm Type
Experimental
Arm Description
Watch and Wait strategy is one of the treatment strategies of advanced rectal cancer, which recommends no immediate surgery with close surveillance.
Arm Title
Adjuvant chemotherapy group
Arm Type
Active Comparator
Arm 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
Procedure
Intervention Name(s)
Colorectal cancer resection combined with liver metastasis resection.
Intervention Description
The preferred surgical approach is resection of the corresponding colon segment with regional lymph node dissection. If conditions permit, synchronous resection of the primary lesion and liver metastases of colorectal cancer can be performed to achieve curative resection.
Intervention Type
Drug
Intervention Name(s)
FOLFOX chemotherapy regimen
Other Intervention Name(s)
CapeOx chemotherapy regimen
Intervention Description
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
Primary Outcome Measure Information:
Title
3-year progression-free survival
Description
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Time Frame
3 years after operation.
Title
5-year progression-free survival
Description
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Time Frame
5 years after operation.
Secondary Outcome Measure Information:
Title
3-year overall survival
Description
Overall survival is defined as the time from randomization to 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 operation.
Title
3-year overall survival
Description
Overall survival is defined as the time from randomization to 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
5 years after operation.
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.
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 genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);
Patients with negative ctDNA after surgery;
ASA grade <IV and/or ECOG performance status score ≤ 2;
Have sufficient understanding of the study and voluntarily sign an informed consent form.
Exclusion Criteria:
Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
Patients with a history of other malignancies;
Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
Patients who are allergic to any component in the study;
Patients who have received other tumor-related investigational drug therapy;
Patients with severe uncontrolled recurrent infections or other serious uncontrolled 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 that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests;
Patients with a history of severe mental illness;
Pregnant or lactating women;
Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the 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
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
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