Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chemotherapy
Herbal therapy
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic colorectal cancer, Chemotherapy, Traditional Chinese Medicine (TCM), Teng-Long-Bu-Zhong-Tang
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the colon or rectum with non-resectable metastatic disease;
- Ages between 18 and 70 years;
- Measurable lesion;
- Karnofsky Performance Status ≥ 60%;
- Estimated life expectancy of at least 6 months;
- Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥90g/L, N > 1.5×10^9/L, platelet≥ 100×10^9/L, normal liver and kidney function;
- Informed consent from the patient.
Exclusion Criteria:
- Symptomatic brain metastasis;
- Adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
- Serious disease of heart, liver, kidney with severe dysfunction;
- Serious complications, such as gastrointestinal tract obstruction and hemorrhage;
- Pregnancy or breast-feeding women;
- Mental or cognitive disorders;
- Be participating other drug trials;
- Who are allergic to the study drug.
Sites / Locations
- Chongqing Three Gorges Central Hospital
- Longhua Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
chemotherapy
Herbal therapy plus chemotherapy
Arm Description
Patients receive chemotherapy until disease progression or unacceptable toxicity
Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
Outcomes
Primary Outcome Measures
Progression-free survival(PFS)
Secondary Outcome Measures
Overall Survival (OS)
Symptoms
Adverse events
Full Information
NCT ID
NCT01975454
First Posted
October 23, 2013
Last Updated
April 18, 2018
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Chongqing Three Gorges Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01975454
Brief Title
Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer
Official Title
A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Chongqing Three Gorges Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Teng-Long-Bu-Zhong-Tang (TLBZT) is a modern anti-cancer herbal formula. Experimental studies have confirmed the anti-cancer potential of TLBZT against colorectal cancer. This trial will evaluate the safety and efficacy of TLBZT based herbal therapy in combination with chemotherapy in patients with metastatic colorectal cancer.
Detailed Description
A phase I/II, multicentric,randomized, controlled clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic colorectal cancer, Chemotherapy, Traditional Chinese Medicine (TCM), Teng-Long-Bu-Zhong-Tang
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
Patients receive chemotherapy until disease progression or unacceptable toxicity
Arm Title
Herbal therapy plus chemotherapy
Arm Type
Experimental
Arm Description
Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Oxaliplatin, Capecitabine
Intervention Description
Oxaliplatin (130 mg/m2) was given intravenously (iv) for at least 2 h on day 1; Capecitabine (1000 mg/m2) was given orally, twice daily on days 1-14. Each cycle was 21 days. Cycles were repeated until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Herbal therapy
Other Intervention Name(s)
Traditional Chinese Medicine
Intervention Description
TLBZT based herbal decoction administered orally twice a day
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
2 months
Title
Symptoms
Time Frame
2 months
Title
Adverse events
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the colon or rectum with non-resectable metastatic disease;
Ages between 18 and 70 years;
Measurable lesion;
Karnofsky Performance Status ≥ 60%;
Estimated life expectancy of at least 6 months;
Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥90g/L, N > 1.5×10^9/L, platelet≥ 100×10^9/L, normal liver and kidney function;
Informed consent from the patient.
Exclusion Criteria:
Symptomatic brain metastasis;
Adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
Serious disease of heart, liver, kidney with severe dysfunction;
Serious complications, such as gastrointestinal tract obstruction and hemorrhage;
Pregnancy or breast-feeding women;
Mental or cognitive disorders;
Be participating other drug trials;
Who are allergic to the study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Hu, MD, PhD
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gang Li, MD
Organizational Affiliation
Chongqing Three Gorges Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing Three Gorges Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Facility Name
Longhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23758730
Citation
Deng S, Hu B, An HM, Du Q, Xu L, Shen KP, Shi XF, Wei MM, Wu Y. Teng-Long-Bu-Zhong-Tang, a Chinese herbal formula, enhances anticancer effects of 5--Fluorouracil in CT26 colon carcinoma. BMC Complement Altern Med. 2013 Jun 8;13:128. doi: 10.1186/1472-6882-13-128.
Results Reference
background
PubMed Identifier
21078269
Citation
Hu B, An HM, Shen KP, Du Q. [Senescence-inducing effects of Chinese herbal medicine Tenglong Buzhong Decoction on human colon carcinoma LS-174-T cells and the mechanism]. Zhong Xi Yi Jie He Xue Bao. 2010 Nov;8(11):1048-52. doi: 10.3736/jcim20101108. Chinese.
Results Reference
background
PubMed Identifier
20550881
Citation
Hu B, An HM, Shen KP, DU Q. [Effects of Tenglong Buzhong Decoction on proliferation and apoptosis of human colon carcinoma cell line LS174T]. Zhong Xi Yi Jie He Xue Bao. 2010 Jun;8(6):575-80. doi: 10.3736/jcim20100611. Erratum In: Zhong Xi Yi Jie He Xue Bao. 2011 Mar;9(3):241. Chinese.
Results Reference
background
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Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer
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