Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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.

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: mFOLFOX6 Drug: XELOX Drug: Placebo ChangTai Keli Drug: ChangTai Keli Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Synergistic Anti-tumor Effect of ChangTai Keli Based on Chemotherapy for Colon Cancer Patients:a Randomized, Parallel-group, Double-blind, Multicenter Clinical Study
Study Start Date : June 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
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.
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.

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.
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: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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. 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;

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): NCT02510118


Contacts
Layout table for location contacts
Contact: Yin Qingfeng, manager 0086-025-85632992 y_qingfeng@163.com

Locations
Layout table for location information
China, Jiangsu
Jiege Huo Recruiting
Nanjing, Jiangsu, China
Contact: Jiege Huo Jiege Huo, Dr    15852031176    Jiegehuo@163.com   
Sponsors and Collaborators
Nanjing NingQi Medicine Science and Technology Co., Ltd.
Jiangsu Province Hospital of Traditional Chinese Medicine
Investigators
Layout table for investigator information
Principal Investigator: Xiaoning Wang, Professor China:Jiangsu province hospital of integrated traditional Chinese and western medicine

Layout table for additonal information
Responsible Party: Nanjing NingQi Medicine Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02510118     History of Changes
Other Study ID Numbers: BL2014099-Y0103
Y0103 ( Registry Identifier: BL2014099 )
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015
Keywords provided by Nanjing NingQi Medicine Science and Technology Co., Ltd.:
ChangTai Keli
Colon cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases