Colon CancerPhase 2/3NCT02510118
Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients
A Phase 2/3 study testing mFOLFOX6, XELOX and ChangTai Keli in people with Colon Cancer, run by Nanjing NingQi Medicine Science and Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- mFOLFOX6, XELOX and ChangTai Keli
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- do not meet the inclusion criteria;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiege Huo
Nanjing, Jiangsu
Jiege Huo Jiege Huo, Dr, 15852031176, Jiegehuo@163.com
About this study
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
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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- mFOLFOX6, XELOX, Placebo ChangTai Keli, ChangTai Keli
- Keywords
- ChangTai Keli, Colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX6Drug
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.
XELOXDrug
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
Placebo ChangTai KeliDrug
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.
ChangTai KeliDrug
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 group | Role | What they receive |
|---|---|---|
| conventional chemotherapy + placebo ChangTai Keli | Experimental | 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. Receives: Drug: mFOLFOX6; Drug: XELOX; Drug: Placebo ChangTai Keli |
| conventional chemotherapy + ChangTai Keli | Experimental | 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. Receives: Drug: mFOLFOX6; Drug: XELOX; Drug: ChangTai Keli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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)
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)
Measured: 3 years
Progression-free Survival (PFS)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing NingQi Medicine Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Xiaoning Wang, Professor, Principal investigator, China:Jiangsu province hospital of integrated traditional Chinese and western medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510118
- Sponsor's protocol ID
- BL2014099-Y0103
- Other IDs
- Y0103
- Status last verified
- Jul 2015
- First submitted
- 12 Jul 2015
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02510118
- Acronym / sponsor ID
- BL2014099-Y0103
- Conditions
- Colon Cancer
- Keywords
- ChangTai Keli, Colon cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Nanjing NingQi Medicine Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional chemotherapy + placebo ChangTai Keli | Experimental | Drug: mFOLFOX6, Drug: XELOX, Drug: Placebo ChangTai KeliPatients 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 | Experimental | Drug: mFOLFOX6, Drug: XELOX, Drug: ChangTai KeliPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- do not meet the inclusion criteria;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFOLFOX6mFOLFOX6 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 | conventional chemotherapy + ChangTai Keli, conventional chemotherapy + placebo ChangTai Keli |
| XELOXXELOX 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 | conventional chemotherapy + ChangTai Keli, conventional chemotherapy + placebo ChangTai Keli |
| Placebo ChangTai KeliAccording 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 | conventional chemotherapy + placebo ChangTai Keli |
| ChangTai KeliAccording 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 | conventional chemotherapy + ChangTai Keli |
Primary outcome
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.
3 secondary outcomes
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.
Investigator-assessed Progression-Free Survival (PFS)
Time frame: 3 years
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoning Wang, Professor principal investigator
China:Jiangsu province hospital of integrated traditional Chinese and western medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing mFOLFOX6, XELOX and ChangTai Keli in people with Colon Cancer, run by Nanjing NingQi Medicine Science and Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yin Qingfeng, manager (0086-025-85632992, y_qingfeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.