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Chemotherapy Combined With CIK Treating Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03084809
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Hao Peng, China Meitan General Hospital

Tracking Information
First Submitted Date  ICMJE March 8, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date March 21, 2017
Actual Study Start Date  ICMJE May 6, 2012
Actual Primary Completion Date September 15, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
Relapse Free Survival in 2 years [ Time Frame: 2 years (24 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • Relapse Free Survival in 3 years [ Time Frame: Follow-up: 3 years ]
  • 5 year Overall Survival [ Time Frame: Follow-up: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy Combined With CIK Treating Colon Cancer
Official Title  ICMJE Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer
Brief Summary Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
Detailed Description Over the past decade, advances in combination chemotherapy regimens for colorectal cancer have led to significant improvement in progression-free and overall survival. Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. Research has demonstrated the median overall survival (OS) in patients received CIK combined with chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4] plan) was significantly increased compared with that in patients received chemotherapy alone. Furthermore, there was a trend toward superior progression-free survival time (PFS) in patients received CIK combined with chemotherapy compared with that in patients received chemotherapy alone. The investigators aim to evaluate the clinical efficacy of chemotherapy (FOLFOX4) combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Group 1: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4]) combined with cytokine-induced killer cells (CIK) Group 2: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4])
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Cytokine-induced Killer Cells
  • Postoperative Complications
  • Survival
Intervention  ICMJE
  • Drug: Cytokine-induced killer cells+ FOLFOX4
    Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. Collected CIK cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.
    Other Name: CIK + Oxaliplatin + leucovorin + 5-FU
  • Drug: FOLFOX4
    Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.
    Other Name: Oxaliplatin + leucovorin + 5-FU
Study Arms  ICMJE
  • Experimental: Cytokine-induced killer cells + FOLFOX4

    Cytokine-induced killer cells + FOLFOX4 intervention:

    Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours.The treatment is given for 4-6 cycles, every 3 weeks.

    Collected cytokine-induced killer cells (CIK) cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.

    Intervention: Drug: Cytokine-induced killer cells+ FOLFOX4
  • Experimental: FOLFOX4

    FOLFOX4 intervention:

    Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.

    Intervention: Drug: FOLFOX4
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2017)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 15, 2014
Actual Primary Completion Date September 15, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Tumor, Nodes, Metastasis (TNM) stage of II or III;
  2. Patients received radical resection of colon cancer;
  3. Pathological diagnosis of adenocarcinoma;
  4. Patients not received radiotherapy and chemotherapy before surgery;
  5. The preoperative examination confirmed without systemic metastasis;
  6. Patient has the Karnofsky score more than 70 points;
  7. Subjects signed informed consent.

Exclusion Criteria:

  1. Patients who was serious allergy to any of the ingredients of drugs used in this study;
  2. Patients who unable to comply with the treatment plan or research program;
  3. Patients with severe systemic disease that the researchers judged will be unable to complete the study;
  4. Patients have severe heart disease, such as myocardial infarction within 6 months;
  5. Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy);
  6. Patients received radiotherapy;
  7. Having other malignant tumors in the last 5 years, but not including who has been cured through surgery and survived 5 year of disease-free;
  8. Any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction, serious arrhythmias, liver, kidney or metabolic diseases within six months).
  9. Patients who do not get effective treatment of inflammation, eye infections or predisposing factors;
  10. Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study;
  11. Patients with serious active infections;
  12. Woman who are pregnant or lactating.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03084809
Other Study ID Numbers  ICMJE CIK-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: whether individual participant data (IPD) could be shared must obtain the consent of the subjects
Responsible Party Hao Peng, China Meitan General Hospital
Study Sponsor  ICMJE China Meitan General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li-Min Wang, Dr. Center for Drug Evaluation, China food and Drug Administration
PRS Account China Meitan General Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP