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Trial record 83 of 721 for:    colon cancer AND 5-FU

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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ClinicalTrials.gov Identifier: NCT02402972
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Collaborators:
Zhejiang University
The Second Affiliated Hospital of Harbin Medical University
Ruijin Hospital
Information provided by (Responsible Party):
Xu jianmin, Fudan University

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastasis Drug: FUDR +oxaliplatin Drug: oxaliplatin+Leucovorin+5-FU Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Controlled Trial: Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer
Study Start Date : February 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IPC plus AC

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.

Drug: FUDR +oxaliplatin
IPC: one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein
Other Name: fluorodeoxyuridine (FUDR)

Drug: oxaliplatin+Leucovorin+5-FU
Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU
Other Name: Leucovorin (LV)

Active Comparator: AC
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.
Drug: oxaliplatin+Leucovorin+5-FU
Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU
Other Name: Leucovorin (LV)




Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 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 Outcome Measures :
  1. overall survival [ Time Frame: 3 year and 5 year ]
    OS was measured from the date of randomization to the date of death from any cause.

  2. metastasis-free survival [ Time Frame: 3 year and 5 year ]
    MFS was defined as the time from randomization to metastasis if metastasis was the first event.

  3. adverse events of Chemotherapy and IPC [ Time Frame: 6 months ]
    toxicity (using NCI CTC 3.0) compared with mFOLFOX6 alone.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402972


Contacts
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Contact: Jianmin Xu, MD 86-13764476150 xujmin@aliyun.com

Locations
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China
Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Wenju Chang, MD    86-21-13764476150      
Principal Investigator: jianmin xu, MD         
Sponsors and Collaborators
Xu jianmin
Zhejiang University
The Second Affiliated Hospital of Harbin Medical University
Ruijin Hospital
Investigators
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Study Director: Hong Jiang, MD Fudan University

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Responsible Party: Xu jianmin, Deputy director of the colorectal cancer center, Fudan University, Fudan University
ClinicalTrials.gov Identifier: NCT02402972     History of Changes
Other Study ID Numbers: IICCAC
82345432 ( Other Grant/Funding Number: Shanghai key research projects )
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: January 2015
Keywords provided by Xu jianmin, Fudan University:
adjuvant chemotherapy
intraportal chemotherapy
prevention
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Oxaliplatin
Floxuridine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action