Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients
2 other identifiers
interventional
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 12, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedAugust 3, 2015
July 1, 2015
1 year
July 12, 2015
July 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Adverse Event (AE)
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.
The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date
Quality of life
Using QLQ-C30 (V3.0) to asses the impact of COPD on a person's life, and how this changes over time.
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.
Secondary Outcomes (3)
symptom
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.
Investigator-assessed Progression-Free Survival (PFS)
3 years
Progression-free Survival (PFS)
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)
Study Arms (2)
conventional chemotherapy + placebo ChangTai Keli
EXPERIMENTALPatients 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.
conventional chemotherapy + ChangTai Keli
EXPERIMENTALPatients 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
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.
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
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- age \> 18 years of age, and the 75 - year - old patient or less;
- fitness score (ECOG PS) 2 minutes or less, expected lifetime \> 6 months;
- volunteered for the clinical research, and sign the informed consent.
You may not qualify if:
- patients with other primary malignant tumors within 1 year;
- intentional, severe liver and kidney disease patients with serious obstacle and function;
- pregnancy or lactation women, mental disorders to cooperate to complete the healer;
- is in other subjects or attended other drugs test interval \< 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiege Huo
Nanjing, Jiangsu, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoning Wang, Professor
China:Jiangsu province hospital of integrated traditional Chinese and western medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2015
First Posted
July 28, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2018
Last Updated
August 3, 2015
Record last verified: 2015-07