Synchronous metastatic colorectal cancer
Conditions
Interventions
Surgery before chemotherapy group:Resection of primary tumor
Chemotherapy before surgery group:Preoperative chemotherapy
Chemotherapy only group:Chemotherapy only
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Patients with histological proven primary colorectal cancer and synchronous unresectable metastases; 3. WHO performance scale 0-2; 4. Patients are evaluated by both surgeons and physicians to have either resectable or unresectable primary colorectal tumor, and unresectable metastatic tumor, with the tolerance for surgery or systemic chemoradiotherapy; 5. Evaluable tumor sites according to RESIST 1.0; 6. Laboratory values obtained 6.5 mmol/L, absolute neutrophil count > 1.5*10^9/L, platelets > 100*10^9/L), renal function (serum creatinine =50 mL/min (calculated according to Cockroft and Gault), liver function (ASAT and ALAT 12 weeks; 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pathologically diagnosed with non-adenocarcinoma, or mixed-type cancer; 2. Signs of bowel obstruction or bleeding from primary tumor that requires surgical intervention; 3. Prior chemotherapy or biological therapy, or radiotherapy treatment for advanced disease; 4. Concurrent severe or uncontrolled disease (i.e. uncontrolled hypertension, congestive heart failure, myocardial infarction < 12 months, chronic active infection); 5. Pregnancy or lactation, or in plan of pregnancy; 6. Signs or symptoms of brain metastases or cerebrovascular accident; 7. Cerebrovascular accident or transient ischemic attack within the past 12 months; 8. Impairment of gastrointestinal function or -disease that may significantly impair the absorption of oral drugs (i.e. uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow tablets); 9. Any concomitant disorder preventing the safe administration of study drugs or surgical procedure; 10. Other malignancies unless the patient is considered to be disease-free and has completed therapy for the malignancy greater than or equal to 12 months prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the past 12 months: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin; 11. Any emotional disturbance that influences the patients congnition; 12. Any infulences from the phychology, family, or the society which caused incompliance of the patient to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;Perioperative morbidity;Perioperative mortality;Incidence rate and type of surgical or non-surgical intervention due to tumor-related local symptoms;Quality of life; | — |
Countries
China
Contacts
Public ContactMeng Qiu, Ziqiang Wang
Outcome results
None listed