Clinical trial NCT02510118: Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colon Cancer
Keywords: ChangTai Keli
Colon cancer
Lead sponsor: Nanjing NingQi Medicine Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Province Hospital of Traditional Chinese Medicine
First posted: 2015-07-28
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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;

Primary outcomes:
measure: Number of Participants With Adverse Event (AE)
timeFrame: The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date
measure: Quality of life
timeFrame: 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:
measure: symptom
timeFrame: 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.
measure: Investigator-assessed Progression-Free Survival (PFS)
timeFrame: 3 years
measure: Progression-free Survival (PFS)
timeFrame: 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)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiege Huo
state: Jiangsu
Study officials:
affiliation: China:Jiangsu province hospital of integrated traditional Chinese and western medicine
name: Xiaoning Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References: