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Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01975454
Recruitment Status : Active, not recruiting
First Posted : November 4, 2013
Last Update Posted : October 18, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Chemotherapy Drug: Herbal therapy Phase 1 Phase 2

Detailed Description:
A phase I/II, multicentric,randomized, controlled clinical trial.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2012
Primary Completion Date : September 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: chemotherapy
Patients receive chemotherapy until disease progression or unacceptable toxicity
Drug: Chemotherapy
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.
Other Names:
  • Oxaliplatin
  • Capecitabine
Experimental: Herbal therapy plus chemotherapy
Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
Drug: Chemotherapy
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.
Other Names:
  • Oxaliplatin
  • Capecitabine
Drug: Herbal therapy
TLBZT based herbal decoction administered orally twice a day
Other Name: Traditional Chinese Medicine


Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival(PFS) [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 2 months ]
  2. Symptoms [ Time Frame: 2 months ]
  3. Adverse events [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, PLT≥ 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975454


Locations
China, Chongqing
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing, China, 404000
China, Shanghai
Longhua Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Chongqing Three Gorges Central Hospital
Investigators
Study Chair: Bing Hu, MD, PhD Longhua Hospital Shanghai University of Traditional Chinese Medicine
Principal Investigator: Gang Li, MD Chongqing Three Gorges Central Hospital
More Information

Publications:
Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01975454     History of Changes
Other Study ID Numbers: TCM-mCRC
LHYY-11495801300 ( Registry Identifier: Longhua Hospital )
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Metastatic colorectal cancer
Chemotherapy
Traditional Chinese Medicine (TCM)
Teng-Long-Bu-Zhong-Tang

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents