Metastatic Colon Cancer, Surgery
Conditions
Keywords
palliative surgery, stage IV colon cancer, chemotherapy
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.
Interventions
PROCEDUREresection of primary tumor
resection of primary lesion with unresectablely metastatic colon cancer
DRUGXELOX
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
DRUGmFOLFOX6
Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 5-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival 2 | 3-year | The first progression time after randomization |
| The rate of adverse events resulted from chemotherapy | 3-year | The ratio of the number of patients experienced adverse events to the total patients |
| The quality of life postoperatively | 3-month, 6-month, 9-month, 12-month, 18-month, 24-month | 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 |
| Progression-free survival 1 | 3-year | The first progression time after diagnosis |
| The rate of postoperative complications | 1-year | The ratio of the number of patients with postoperative complications to the total patients |
| The proportion of surgical intervention in control group | 1-year | — |
| Objective response rate | 1-year | — |
Countries
China
Contacts
Primary ContactXinxiang Li
Backup ContactQingguo Li
Outcome results
None listed