Back to resultsThe Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer
Primary Purpose
Metastatic Colon Cancer, Surgery
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
resection of primary tumor
XELOX
mFOLFOX6
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colon Cancer focused on measuring palliative surgery, stage IV colon cancer, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 75 years old
- ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
- Pathological diagnosis of colon cancer adenocarcinoma
- At least one measurable objective tumor lesions which could be evaluated.
- Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
- ANC≥1.5*109/L；PLT≥90*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
- No systemic chemotherapy
- Patients with voluntary participation, and sign the informed consent
Exclusion Criteria:
- Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
- Multiple primary colorectal carcinoma
- Malignant peritoneal effusion or metastatic carcinoma of the peritoneum
- Uncontrolled pleural effusion
- Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
- With brain metastasis or meningeal metastasis
- Pregnancy or breast-feeding women
- Alcohol or drug addictions
- There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chemotherapy plus surgery
Chemotherapy alone
Arm Description
Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Progression-free survival 1
The first progression time after diagnosis
Progression-free survival 2
The first progression time after randomization
The rate of adverse events resulted from chemotherapy
The ratio of the number of patients experienced adverse events to the total patients
The quality of life postoperatively
The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24
Objective response rate
The rate of postoperative complications
The ratio of the number of patients with postoperative complications to the total patients
The proportion of surgical intervention in control group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04416854
Brief Title
The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer
Official Title
The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colon Cancer, Surgery
Keywords
palliative surgery, stage IV colon cancer, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
627 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy plus surgery
Arm Type
Experimental
Arm Description
Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
Arm Title
Chemotherapy alone
Arm Type
Active Comparator
Arm Description
Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
Intervention Type
Procedure
Intervention Name(s)
resection of primary tumor
Intervention Description
resection of primary lesion with unresectablely metastatic colon cancer
Intervention Type
Drug
Intervention Name(s)
XELOX
Intervention Description
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6
Intervention Description
Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
5-year
Secondary Outcome Measure Information:
Title
Progression-free survival 1
Description
The first progression time after diagnosis
Time Frame
3-year
Title
Progression-free survival 2
Description
The first progression time after randomization
Time Frame
3-year
Title
The rate of adverse events resulted from chemotherapy
Description
The ratio of the number of patients experienced adverse events to the total patients
Time Frame
3-year
Title
The quality of life postoperatively
Description
The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24
Time Frame
3-month, 6-month, 9-month, 12-month, 18-month, 24-month
Title
Objective response rate
Time Frame
1-year
Title
The rate of postoperative complications
Description
The ratio of the number of patients with postoperative complications to the total patients
Time Frame
1-year
Title
The proportion of surgical intervention in control group
Time Frame
1-year
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:
75 years old
ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
Pathological diagnosis of colon cancer adenocarcinoma
At least one measurable objective tumor lesions which could be evaluated.
Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
ANC≥1.5*109/L；PLT≥90*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
No systemic chemotherapy
Patients with voluntary participation, and sign the informed consent
Exclusion Criteria:
Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
Multiple primary colorectal carcinoma
Malignant peritoneal effusion or metastatic carcinoma of the peritoneum
Uncontrolled pleural effusion
Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
With brain metastasis or meningeal metastasis
Pregnancy or breast-feeding women
Alcohol or drug addictions
There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinxiang Li
Phone
+8613761291659
Email
1149lxx@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qingguo Li
Phone
+8618918298120
Email
qingguoli@fudan.edu.cn
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinxiang Li, MD,PhD
Phone
+8613918176716
Email
lxx1149@163.com
First Name & Middle Initial & Last Name & Degree
Qingguo Li, MD,PhD
Phone
+8618918298120
Email
qingguoli@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xinxiang Li, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer
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