A Multi-center Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer
2 other identifiers
interventional
700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 colorectal-cancer
Started Feb 2015
Typical duration for phase_3 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 20, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMarch 31, 2015
January 1, 2015
5 years
March 20, 2015
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease-free survival
DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause.
up to 5 year
Secondary Outcomes (3)
overall survival
3 year and 5 year
metastasis-free survival
3 year and 5 year
adverse events of Chemotherapy and IPC
6 months
Study Arms (2)
IPC plus AC
EXPERIMENTALpatients treated with intraoperative intraportal chemotherapy (IPC) plus adjuvant chemotherapy (AC; mFOLFOX6).; IPC: During the operation, one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein within 5 minutes just before ligation. AC: All patients received mFOLFOX6 adjuvant chemotherapy, consisting of a 2-h infusion of 85 mg/m2 oxaliplatin given simultaneously with a 2-h infusion of 400 mg/m2 LV, followed by a bolus of 400 mg/m2 5-FU, and then a continuous infusion of 2000 mg/m2 5-FU given on 2 consecutive days by intravenous pumping every 14 days for 12 cycles.\[1\] Adverse events were categorized according to National Cancer Institute Common Toxicity Criteria, version 3.0.
AC
ACTIVE COMPARATORpatients treated with adjuvant chemotherapy (AC; mFOLFOX6) alone after surgery; Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy, consisting of a 2-h infusion of 85 mg/m2 oxaliplatin given simultaneously with a 2-h infusion of 400 mg/m2 LV, followed by a bolus of 400 mg/m2 5-FU, and then a continuous infusion of 2000 mg/m2 5-FU given on 2 consecutive days by intravenous pumping every 14 days for 12 cycles.\[1\] Adverse events were categorized according to National Cancer Institute Common Toxicity Criteria, version 3.0.
Interventions
IPC: one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein
Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU
Eligibility Criteria
You may qualify if:
- Age ≥ 18 and ≤ 75 years;
- 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).
- 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)
- Performance status (ECOG) 0\~1
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
- 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);
- Written informed consent for participation in the trial.
You may not qualify if:
- Previous exposure to prior cancer therapy (chemotherapy, radiotherapy or intervention therapy) for colon cancer.
- Patients with known hypersensitivity reactions to any of the components of the study treatments.
- 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
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Pre-existing peripheral neuropathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xu jianminlead
- Zhejiang Universitycollaborator
- The Second Affiliated Hospital of Harbin Medical Universitycollaborator
- Ruijin Hospitalcollaborator
Study Sites (1)
Zhongshan Hospital, Fudan University
Shanghai, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hong Jiang, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy director of the colorectal cancer center, Fudan University
Study Record Dates
First Submitted
March 20, 2015
First Posted
March 31, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2020
Study Completion
February 1, 2022
Last Updated
March 31, 2015
Record last verified: 2015-01