Overview

This trial is active, not recruiting.

Condition metastatic colorectal cancer
Treatments chemotherapy, herbal therapy
Phase phase 1/phase 2
Sponsor Shanghai University of Traditional Chinese Medicine
Collaborator Chongqing Three Gorges Central Hospital
Start date April 2012
End date September 2016
Trial size 62 participants
Trial identifier NCT01975454, LHYY-11495801300, TCM-mCRC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients receive chemotherapy until disease progression or unacceptable toxicity
chemotherapy Oxaliplatin
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.
(Experimental)
Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
chemotherapy Oxaliplatin
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.
herbal therapy Traditional Chinese Medicine
TLBZT based herbal decoction administered orally twice a day

Primary Outcomes

Measure
Progression-free survival(PFS)
time frame: 2 months

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: 2 months
Symptoms
time frame: 2 months
Adverse events
time frame: 1 month

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Principal investigator Gang Li, MD
Description A phase I/II, multicentric,randomized, controlled clinical trial.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Shanghai University of Traditional Chinese Medicine.