Clinical trial NCT02777788: Curative Study of Chinese Traditional Medicine to Treat Lung Cancer
Official title: Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cancer
Keywords: Chinese Traditional Medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Chest Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2016-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.

Detailed description: Lung cancer is the most common malignant tumor in the world with about 80%-85% non small cell lung cancer.

The investigators perform a multi-center, randomized, controlled, prospective study in patients with advanced NSCLC. Patients are randomized over observational group(Chinese patent drugs plus chemotherapy), and control group (chemotherapy). The investigators will observe 2 cycles and after that regular follow-up will be arranged.

The primary end point is: Objective response rate;

The secondary end points are:

1. progression-free survival(PFS);
2. overall survival(OS);
3. Time to Progression (TTP);
4. quality of life questionnaire（QOL);
5. other end points are: Toxicity, side effects and security of the treatments will be assessed at the same time.

The investigators expect that integrated TCM combined with chemotherapy has a better efficacy on enhancing Objective response rate，prolonging PFS, OS, improving QOL, reducing the adverse reaction of patients than that of chemotherapy.Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.

Eligibility criteria: Inclusion Criteria:

1. Pathologically or cytologically confirmed of stage Ⅲb-Ⅳ NSCLC
2. Ages Eligible for Study: 18-65 years old;
3. Physical status score (ECOG PS) ≤ 2 scores；
4. Estimated life expectancy of at least 6 months；
5. Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥10g/dL, absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥80\*109/L, Liver and kidney function is normal;
6. Informed consent from the patient.

Exclusion Criteria:

1. Patient with other malignant tumor except NSCLC 5 years previous to study entry.
2. Patients who have received targeted drug treatment；
3. Serious problem of heart, liver or kidney with severe dysfunction;
4. Pregnant or child breast feeding women;
5. Mental or cognitive disorders;
6. Participating in other drug trials;
7. Who are allergic to the study drug.
8. Diabetic patients.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months
Secondary outcomes:
measure: Objective response rate
timeFrame: up to 2 months
measure: Time-to-Progression
timeFrame: up to 2 months
measure: Number of participants with treatment-related quality of life as assessed by FACT-L4.0
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: HEGEN LI
role: STUDY_DIRECTOR
References: