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

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

mFOLFOX6

XELOX

Placebo ChangTai Keli

ChangTai Keli

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring ChangTai Keli, Colon cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;

Sites / Locations

Jiege HuoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

conventional chemotherapy + placebo ChangTai Keli

conventional chemotherapy + ChangTai Keli

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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)

Progression-free Survival (PFS)

Full Information

NCT ID

NCT02510118

First Posted

July 12, 2015

Last Updated

July 30, 2015

Sponsor

Nanjing NingQi Medicine Science and Technology Co., Ltd.

Collaborators

Jiangsu Province Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02510118

Brief Title

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

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanjing NingQi Medicine Science and Technology Co., Ltd.

Collaborators

Jiangsu Province Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

ChangTai Keli, Colon cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

conventional chemotherapy + placebo ChangTai Keli

Arm Type

Experimental

Arm Description

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.

Arm Title

conventional chemotherapy + ChangTai Keli

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

mFOLFOX6

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

XELOX

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo ChangTai Keli

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

ChangTai Keli

Intervention Description

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 Measure Information:

Title

Number of Participants With Adverse Event (AE)

Description

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.

Time Frame

The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date

Title

Quality of life

Description

Using QLQ-C30 (V3.0) to asses the impact of COPD on a person's life, and how this changes over time.

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.

Secondary Outcome Measure Information:

Title

symptom

Description

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.

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.

Title

Investigator-assessed Progression-Free Survival (PFS)

Description

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)

Time Frame

3 years

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yin Qingfeng, manager

Phone

0086-025-85632992

Email

y_qingfeng@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaoning Wang, Professor

Organizational Affiliation

China:Jiangsu province hospital of integrated traditional Chinese and western medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jiege Huo

City

Nanjing

State/Province

Jiangsu

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiege Huo Jiege Huo, Dr

Phone

15852031176

Email

Jiegehuo@163.com

Colon Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial