Efficacy Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma

NCT01745302 | Unknown DMC

• 1 other identifier: LH126
• Study Type: observational
• Target: 470
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators performed a randomized, double-blind controlled, prospective study method on observation of Traditional Chinese Medicine combined with targeted therapy to prolong the efficacy of long-term survival of advanced pulmonary Adenocarcinoma patients.The investigators plan to involve 404 cases for observation in 3 years (202 cases for each group), expecting that integrated TCM combined with targeted therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving QOL of patients than that of targeted therapy.

Conditions

Cancer

Keywords

lung cancer; traditional Chinese medicine; EGFR-TKI

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  2 months

Secondary Outcomes (4)

• Overall response rate(ORR)

  2 months

• overall survival(OS)

  2 months

• Time-to-Progression(TTP)

  2 months

• quality of life(QOL),

  2 months

Study Arms (2)

TCM plus EGFR-TKIs

TCM:oral granules,YangYinFang or YiQiFang or YiQiYangYinFang,four packages,twice a day, six months; EGFR-TKIs:oral tablet,Gefitinib 250mg daily or Erlotinib 150mg daily or Icotinib 125 mg three times a day ，until progression or unacceptable toxicity;

Drug: TCM; Drug: EGFR-TKI

Placebo plus EGFR-TKIs

TCM Placebo:oral granules,YangYinFang or YiQiFang or YiQiYangYinFang,four packages,twice a day ,six months; EGFR-TKIs:oral tablet,Gefitinib 250mg daily or Erlotinib 150mg daily or Icotinib 125 mg three times a day until progression or unacceptable toxicity;

Drug: EGFR-TKI

Interventions

TCM DRUG

TCM: In China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.The herbal treatment is adapted to the syndromes.

Also known as: YangYinFang:four packages twice a day, YiQiFang :four packages twice a day, YiQiYangYinFang:four packages twice a day

TCM plus EGFR-TKIs

EGFR-TKI DRUG

Erlotinib 150 mg oral once a day or Gefitinib 250 mg oral once a day or Icotinib 125 mg oral three times a day

Also known as: Erlotinib:150 mg oral, once a day,Tarceva, Gefitinib:250 mg oral, once a day,Iressa, Icotinib:125 mg oral,three times a day,Conmana

Placebo plus EGFR-TKIs; TCM plus EGFR-TKIs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

pulmonary adenocarcinoma patients with stage Ⅲa～Ⅳ; TCM syndromes are deficiency of Yin, deficiency of Qi and deficiency of both Qi and Yin.

You may qualify if:

• Pathologically or cytologically confirmed of stage IIIa-IV NSCLC with adenocarcinoma histology;
• Patient with mutated EGFR will subject to first line target thearapy；patients received at least one cycle platinum-containing chemotherapy regimens with disease progression/recurrence， or intolerant/refuse to proceed with chemotherapy will explore second line target therapy;
• Physical status score (ECOG PS) ≤ 2 scores;
• Age ≥18 years old;
• Estimated life expectancy of at least 12 weeks;
• Participants have no major organ dysfunction: hemoglobin ≥9 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;
• Informed consent from the patient.

You may not qualify if:

• Patient with other malignant tumor except NSCLC 5 years previous to study entry.
• Wild type EGFR; already receiving targeted treatment or other anticancer treatment such as palliative radiotherapy if it was not finished over 4 weeks or operation was not over 4 weeks before the first drug administration ;
• Estimated life expectancy less than 12 weeks;
• Brain metastasis (controlled brain metastasis and steroid free need is excluded).
• 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

Related Publications (1)

• Jiao L, Xu J, Sun J, Chen Z, Gong Y, Bi L, Lu Y, Yao J, Zhu W, Hou A, Feng G, Jia Y, Shen W, Li Y, Zhang Z, Chen P, Xu L. Chinese Herbal Medicine Combined With EGFR-TKI in EGFR Mutation-Positive Advanced Pulmonary Adenocarcinoma (CATLA): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Front Pharmacol. 2019 Jul 2;10:732. doi: 10.3389/fphar.2019.00732. eCollection 2019.

  PMID: 31333456 DERIVED

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ling Xu, MD & PhD

  Longhua Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Longhua Hospital

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: December 10, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07