Clinical Study of Chinese Medicine Plus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer

NCT02900742 | Completed Phase 3 DMC

• 1 other identifier: LH128
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators performed a randomized, prospective study method on observation of Traditional Chinese Medicine(TCM) combined with chemotherapy maintenance to prolong the efficacy of long-term survival of advanced non small cell lung cancer(NSCLC) patients.The investigators plan to involve 100 cases for observation in 3 years (50 cases for chemotherapy maintenance, 50 cases for chemotherapy maintenance plus TCM), expecting that integrated TCM combined with chemotherapy maintenance has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of chemotherapy maintenance.

Conditions

Cancer

Keywords

lung cancer; traditional Chinese medicine; maintenance therapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  It referred to the interval time from the first date of randomization to that of death for any reason, the end of the study, or loss of follow-up.

  2 months

Secondary Outcomes (4)

• Progression-free survival(PFS)

  2 months

• Overall response rate(ORR)

  2 months

• Quality of life (QOL)

  2 months

• Quality of life(QOL)

  2 months

Other Outcomes (2)

• TCM symptoms changes

  2 months

• Safety assessment evaluated according to Common Toxicity Criteria

  2 months

Study Arms (2)

TCM granules plus Chemotherapy

EXPERIMENTAL

TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day until progression or unacceptable toxicity; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.

Drug: YiQiFang; Drug: YangYinFang; Drug: YiQiYangYinFang; Drug: Gemcitabine®; Drug: Pemetrexed®; Drug: Docetaxel®

Placebo granules plus Chemotherapy

PLACEBO COMPARATOR

Placebo granules: oral granules, oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.

Drug: Gemcitabine®; Drug: Pemetrexed®; Drug: Docetaxel®; Drug: placebo granules

Interventions

YiQiFang DRUG

Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiFang: Patients with Qi deficiency syndrome are administered two packages of each benefiting Qi and detoxication recipe, four packages, twice a day, until progression or unacceptable.

TCM granules plus Chemotherapy

YangYinFang DRUG

Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YangYinFang: Patients with Yin deficiency syndrome are administered two packages of each benefiting Yin and detoxication recipe, four packages, twice a day, until progression or unacceptable.

TCM granules plus Chemotherapy

YiQiYangYinFang DRUG

Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiYangYinFang: Patients with Qi and Yin deficiency syndrome are administered one package of each benefiting Qi and benefiting Yin and two packages of detoxication recipe, four packages, twice a day, until progression or unacceptable.

TCM granules plus Chemotherapy

Gemcitabine® DRUG

"Gemcitabinie®","Gemzar",1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days until progression or unacceptable toxicity develops.

Also known as: Gemzar

Placebo granules plus Chemotherapy; TCM granules plus Chemotherapy

Pemetrexed® DRUG

"Pemetrexed®","Alimta",500 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity develops.

Also known as: Alimta

Placebo granules plus Chemotherapy; TCM granules plus Chemotherapy

Docetaxel® DRUG

"Docetaxel®","Taxotere",75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.

Also known as: Taxotere

Placebo granules plus Chemotherapy; TCM granules plus Chemotherapy

placebo granules DRUG

Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, four packages, twice a day, until progression or unacceptable.

Placebo granules plus Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically or cytologically confirmed of stage IIIa-IV NSCLC;
• The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD);
• At the age of 18 -75 years old;
• Physical status score (ECOG PS) ≤ 2 scores;
• Estimated life expectancy of at least 12 weeks;
• Participants have no major organ dysfunction: hemoglobin ≥10 g/dL, absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥100 \*109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;
• Planning for chemotherapy maintenance.
• Informed consent from the patient.

You may not qualify if:

• The efficacy evaluation of the first-line therapy is progressive disease;
• Patient with other malignant tumor except NSCLC 5 years previous to study entry;
• Patient already receiving targeted therapy or other anticancer treatment;
• Allergic to chemotherapy drugs;
• Estimated life expectancy less than 12 weeks;
• History of cardiovascular disease: Congestive Heart Failure \> grade II in NYHA.Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months;
• Pregnant or child breast feeding women;
• Mental or cognitive disorders.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Shanghai Chest Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Related Publications (1)

• Wang Q, Jiao L, Wang S, Chen P, Bi L, Zhou D, Yao J, Li J, Chen Z, Jia Y, Zhang Z, Shen W, Zhu W, Xu J, Gao Y, Gong Y, Xu L. Maintenance Chemotherapy With Chinese Herb Medicine Formulas vs. With Placebo in Patients With Advanced Non-small Cell Lung Cancer After First-Line Chemotherapy: A Multicenter, Randomized, Double-Blind Trial. Front Pharmacol. 2018 Nov 6;9:1233. doi: 10.3389/fphar.2018.01233. eCollection 2018.

  PMID: 30459612 BACKGROUND

Related Links

• full paper

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms

Interventions

Gemcitabine; Pemetrexed; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ling Xu, MD & PhD

  Longhua Hospital Affiliated to Shanghai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: September 14, 2016
• Study Start: March 1, 2013
• Primary Completion: December 30, 2016
• Study Completion: June 1, 2017
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share