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Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients

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ClinicalTrials.gov Identifier: NCT02510118
Recruitment Status : Unknown
Verified July 2015 by Nanjing NingQi Medicine Science and Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 28, 2015
Last Update Posted : August 3, 2015
Sponsor:
Collaborator:
Jiangsu Province Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Nanjing NingQi Medicine Science and Technology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 12, 2015
First Posted Date  ICMJE July 28, 2015
Last Update Posted Date August 3, 2015
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2015)
  • Number of Participants With Adverse Event (AE) [ Time Frame: The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date ]
    Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug.
  • Quality of life [ Time Frame: Change from Baseline in the QLQ-C30 (V3.0)at the week 2, 4, 6, 8, 10,13, 26 of the treatment phase, the week 13, 26, 39 and 52, 65, 78, 91, 104, 117, 130 of the followup phase. ]
    Using QLQ-C30 (V3.0) to asses the impact of COPD on a person's life, and how this changes over time.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02510118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2015)
  • symptom [ Time Frame: Change from Baseline in symptom score at the week 2, 4, 6, 8, 10,13, 26 of the treatment phase, the week 13, 26, 39 and 52, 65, 78, 91, 104, 117, 130 of the followup phase. ]
    Using TCM scale to assess a patient's level of syptom. The symptom scale is a simple grading system that scored from 0, 2, 4, 6.
  • Investigator-assessed Progression-Free Survival (PFS) [ Time Frame: 3 years ]
    The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression was determined through radiological imaging and based on the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
  • Progression-free Survival (PFS) [ Time Frame: the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later) ]
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 Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients
Official Title  ICMJE Synergistic Anti-tumor Effect of ChangTai Keli Based on Chemotherapy for Colon Cancer Patients:a Randomized, Parallel-group, Double-blind, Multicenter Clinical Study
Brief Summary The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients by a randomized, parallel-group, double-blind, multicenter clinical study.
Detailed Description Although many therapies exist and are being developed to relieve symptoms for colon cancer, there are few randomized controlled clinical trials to evaluate comprehensive Traditional Chinese medicine (TCM) interventions in colon cancer. The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients. This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the synergistic anti-tumor effect of TCM on colon cancer patients. Following a run-in period, approximately 360 subjects will be randomly assigned to conventional chemotherapy treatment group, ChangTai Keli and conventional chemotherapy treatment group for 26 weeks. After the 26 weeks treatment period, subjects in two treatments arms will follow-up 36 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • Drug: mFOLFOX6
    mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m^2) via ambulatory pump administered for a period of 46 to 48 hours.
  • Drug: XELOX
    XELOX is a combination therapy of Oxaliplatin 130mg/ m^2 d1 Intravenous infusion, every 3 weeks. and Capecitabine 1000mg/m^2 bid, days 1-14, every 3 weeks
  • Drug: Placebo ChangTai Keli
    According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of dampness stasis type of spleen deficiency will be given placebo ChangTai Keli, twice daily for 26 weeks for lower dosage.
  • Drug: ChangTai Keli
    According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of dampness stasis type of spleen deficiency will be given placebo ChangTai Keli, twice daily for 26 weeks for lower dosage.
Study Arms  ICMJE
  • Experimental: conventional chemotherapy + placebo ChangTai Keli
    Patients in this group will be given conventional chemotherapy medicine: modified FOLFOX6 (mFOLFOX6) chemotherapy or XELOX recommended by treatment guidelines for colon cancer, and the placebo ChangTai Keli corresponding to the traditional Chinese syndrome of dampness stasis type of spleen deficiency.
    Interventions:
    • Drug: mFOLFOX6
    • Drug: XELOX
    • Drug: Placebo ChangTai Keli
  • Experimental: conventional chemotherapy + ChangTai Keli
    Patients in this group will be given conventional chemotherapy medicine: modified FOLFOX6 (mFOLFOX6) chemotherapy or XELOX recommended by treatment guidelines for colon cancer, and the ChangTai Keli corresponding to the traditional Chinese syndrome of dampness stasis type of spleen deficiency, a herbal extract twice daily for 26 weeks for lower dosage.
    Interventions:
    • Drug: mFOLFOX6
    • Drug: XELOX
    • Drug: ChangTai Keli
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 27, 2015)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. collaboration from hospital oncology patients in hospital. Confirmed by pathology or cytology for colon cancer, Ⅱ A - Ⅳ period of patients with colon cancer line (or late postoperative palliative chemotherapy).
  2. age > 18 years of age, and the 75 - year - old patient or less;
  3. fitness score (ECOG PS) 2 minutes or less, expected lifetime > 6 months;
  4. volunteered for the clinical research, and sign the informed consent.

Exclusion Criteria:

  1. patients with other primary malignant tumors within 1 year;
  2. intentional, severe liver and kidney disease patients with serious obstacle and function;
  3. pregnancy or lactation women, mental disorders to cooperate to complete the healer;
  4. is in other subjects or attended other drugs test interval < 3 months.
  5. do not meet the inclusion criteria;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02510118
Other Study ID Numbers  ICMJE BL2014099-Y0103
Y0103 ( Registry Identifier: BL2014099 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nanjing NingQi Medicine Science and Technology Co., Ltd.
Study Sponsor  ICMJE Nanjing NingQi Medicine Science and Technology Co., Ltd.
Collaborators  ICMJE Jiangsu Province Hospital of Traditional Chinese Medicine
Investigators  ICMJE
Principal Investigator: Xiaoning Wang, Professor China:Jiangsu province hospital of integrated traditional Chinese and western medicine
PRS Account Nanjing NingQi Medicine Science and Technology Co., Ltd.
Verification Date July 2015

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