Colorectal Neoplasms, Liver Neoplasms, Neoplasm Metastasis
Conditions
Keywords
Colorectal Neoplasms, Liver, Neoplasm Metastasis, Tegafur, oxaliplatin
Brief summary
In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal cancer resection.
Detailed description
In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis and improve survival in patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation. Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms.Arm A: 5-FU 1g and oxaliplatin 100mg + curative resection (study group, n=132). Arm B: curative resection alone (control group, n=132).Follow-up: X-ray, US, CT, blood test, colonoscopy,every 3months. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.
Interventions
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg+ curative resection + mFOLFOX6.
PROCEDUREcolorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. All patients in both arms accept curative resection of colorectal cancer,and accept standard adjuvant chemotherapy (mFOLFOX6).
Sponsors
Xu jianmin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum 2. WHO performance status of 0 or 1 3. Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan 4. Written informed consent for participation in the trial.
Exclusion criteria
1. has prior other malignant cancer 2. has severe major organ dysfunction 3. has prior cancer therapy before surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 years disease-free survival | 3 years after operation | PFS will be defined as the period from the first day of CRC resection to the date of disease recurrence or to death. |
Secondary
| Measure | Time frame |
|---|---|
| 3 years overall survival and metastasis-free survival | 3 years after operation |
Countries
China
Contacts
Primary Contactjianmin Xu, PHD
Outcome results
None listed