Curative Study of Chinese Traditional Medicine to Treat Lung Cancer

NCT02777788 | Unknown Phase 2 DMC

• 1 other identifier: ZY3-CCCX-3-3023
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer

Keywords

Chinese Traditional Medicine

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  The progression disease is assessed based on CT every 2 months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer.

  From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months

Secondary Outcomes (3)

• Objective response rate

  up to 2 months

• Time-to-Progression

  up to 2 months

• Number of participants with treatment-related quality of life as assessed by FACT-L4.0

  21 days

Study Arms (2)

chemotherapy

ACTIVE COMPARATOR

Eligible subjects will be treated with platinum-doublet 2 cycles chemotherapy:pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin. Each cycle was 21-days. Dosage:pemetrexed i.v.500mg/m2 d1 ; docetaxel i.v.75mg/m2 d1 ; gemcitabine i.v.1250 mg/m2 d1,d8 ; paclitaxel i.v.175mg/m2 d1 ; vinorelbine i.v.25mg/m2 d1,d8; carboplatin i.v.area under curve (AUC) 5 d1 ；cis-platinum i.v.75mg/m2 d1（or divided into 3days）；nedaplatin i.v.80mg/m2 d1.

Drug: pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin

TCM combined chemotherapy

EXPERIMENTAL

TCM：JinFuKang plus XingZaoRuanJian, chemotherapy will be the same. JinFuKang po.tid.30ml d6-d21 XingZaoRuanJian po.tid.30ml d6-d21

Drug: JinFuKang; Drug: XingZaoRuanJian

Interventions

pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin DRUG

chemotherapy

JinFuKang DRUG

treated with chemotherapy

Also known as: JinFuKang oral liquid

TCM combined chemotherapy

XingZaoRuanJian DRUG

treated with chemotherapy

Also known as: RuanHuaTang

TCM combined 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 Ⅲb-Ⅳ NSCLC
• Ages Eligible for Study: 18-65 years old;
• Physical status score (ECOG PS) ≤ 2 scores；
• Estimated life expectancy of at least 6 months；
• 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;
• Informed consent from the patient.

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Neoplasms

Interventions

jinfukang; Pemetrexed; nedaplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• HEGEN LI

  Shanghai University of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 19, 2016
• Study Start: September 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 10, 2017

Record last verified: 2017-05