Back to resultsA Multi-center Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer
Primary Purpose
Colorectal Cancer, Metastasis
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
FUDR +oxaliplatin
oxaliplatin+Leucovorin+5-FU
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adjuvant chemotherapy, intraportal chemotherapy, prevention
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Zhongshan Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IPC plus AC
AC
Arm Description
patients 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.
patients 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.
Outcomes
Primary Outcome Measures
disease-free survival
DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause.
Secondary Outcome Measures
overall survival
OS was measured from the date of randomization to the date of death from any cause.
metastasis-free survival
MFS was defined as the time from randomization to metastasis if metastasis was the first event.
adverse events of Chemotherapy and IPC
toxicity (using NCI CTC 3.0) compared with mFOLFOX6 alone.
Full Information
NCT ID
NCT02402972
First Posted
March 20, 2015
Last Updated
March 25, 2015
Sponsor
Xu jianmin
Collaborators
Zhejiang University, The Second Affiliated Hospital of Harbin Medical University, Ruijin Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02402972
Brief Title
A Multi-center Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer
Official Title
A Multi-center Randomized Controlled Trial: Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xu jianmin
Collaborators
Zhejiang University, The Second Affiliated Hospital of Harbin Medical University, Ruijin Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastasis
Keywords
adjuvant chemotherapy, intraportal chemotherapy, prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPC plus AC
Arm Type
Experimental
Arm Description
patients 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.
Arm Title
AC
Arm Type
Active Comparator
Arm Description
patients 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.
Intervention Type
Drug
Intervention Name(s)
FUDR +oxaliplatin
Other Intervention Name(s)
fluorodeoxyuridine (FUDR)
Intervention Description
IPC: one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein
Intervention Type
Drug
Intervention Name(s)
oxaliplatin+Leucovorin+5-FU
Other Intervention Name(s)
Leucovorin (LV)
Intervention Description
Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU
Primary Outcome Measure Information:
Title
disease-free survival
Description
DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause.
Time Frame
up to 5 year
Secondary Outcome Measure Information:
Title
overall survival
Description
OS was measured from the date of randomization to the date of death from any cause.
Time Frame
3 year and 5 year
Title
metastasis-free survival
Description
MFS was defined as the time from randomization to metastasis if metastasis was the first event.
Time Frame
3 year and 5 year
Title
adverse events of Chemotherapy and IPC
Description
toxicity (using NCI CTC 3.0) compared with mFOLFOX6 alone.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Xu, MD
Phone
86-13764476150
Email
xujmin@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Jiang, MD
Organizational Affiliation
Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenju Chang, MD
Phone
86-21-13764476150
First Name & Middle Initial & Last Name & Degree
jianmin xu, MD
12. IPD Sharing Statement
Learn more about this trial
A Multi-center Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer
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