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

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

Interventions

DRUG

YiQiFang

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.

DRUG

YangYinFang

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.

DRUG

YiQiYangYinFang

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.

DRUG

Gemcitabine®

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

DRUG

Pemetrexed®

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

DRUG

Docetaxel®

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

DRUG

placebo granules

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.

Sponsors & Collaborators

• Shanghai Chest Hospital

  collaborator OTHER

• Shanghai Pulmonary Hospital, Shanghai, China

  collaborator OTHER

• Shanghai University of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Ling Xu, MD & PhD · Longhua Hospital Affiliated to Shanghai University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2016-12-30

Completion

2017-06-01