Colorectal Cancer, Metastasis
Conditions
Keywords
adjuvant chemotherapy, intraportal chemotherapy, prevention
Brief summary
To investigate whether intraoperative intraportal chemotherapy combined with adjuvant chemotherapy as treatment could improve disease-free survival (DFS) in patients with curative colorectal cancer resection compared with adjuvant chemotherapy alone. This is a prospective, blind (doctors who done outcome measures were masked), multi-center, 2-arm randomized controlled trial.
Interventions
DRUGFUDR +oxaliplatin
IPC: one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein
DRUGoxaliplatin+Leucovorin+5-FU
Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU
Sponsors
Zhejiang University
The Second Affiliated Hospital of Harbin Medical University
Ruijin Hospital
Xu jianmin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 75 years; 2. Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin). 3. Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system) 4. Performance status (ECOG) 0\ 1 5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization) 6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization); 7. Written informed consent for participation in the trial.
Exclusion criteria
1. Previous exposure to prior cancer therapy (chemotherapy, radiotherapy or intervention therapy) for colon cancer. 2. Patients with known hypersensitivity reactions to any of the components of the study treatments. 3. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix 4. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding 5. Known drug abuse/ alcohol abuse 6. Legal incapacity or limited legal capacity 7. Pre-existing peripheral neuropathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | up to 5 year | DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3 year and 5 year | OS was measured from the date of randomization to the date of death from any cause. |
| metastasis-free survival | 3 year and 5 year | MFS was defined as the time from randomization to metastasis if metastasis was the first event. |
| adverse events of Chemotherapy and IPC | 6 months | toxicity (using NCI CTC 3.0) compared with mFOLFOX6 alone. |
Countries
China
Contacts
Primary ContactJianmin Xu, MD
Outcome results
None listed