CancerNCT01745302
Efficacy Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma
An observational study of Cancer, run by Shanghai University of Traditional Chinese Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- TCM and EGFR-TKI
- Type of treatment
- Pill or oral medicine
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma: a Randomized Double-blind Controlled Clinical Trial
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.
Read the detailed description
At present, the third generation of platinum-based regimens (NCCN clinical practice guidelines recommended the use of vinorelbine or gemcitabine, or Taxol, etc.) is the first-line treatment for advanced lung cancer patients. Its effective rate is 20-30%, the median survival time is 7-9 months, 1-year and 2-year survival rate is 31-36% and 10-13% respectively. The efficacy has reached the platform and it is difficult to have more breakthroughs. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) such as Iressa and Erlotinib have proved effective in first or second line therapy for advanced non-small cell lung cancer(NSCLC).First-SIGNAL and IPASS research have laid first-line status for gefitinib in treatment of NSCLC and the progression-free survival time was maintained at 9-10 months. EGFR-TKIs treatment is simple, well tolerated, drug side effects, etc. There are also a rash, diarrhea and other adverse reactions, affecting the quality of life of patients with serious or even give patients a great deal of pain.Literature and our preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival time and improve quality of life QOL, but high-level evidences are needed.
The investigators perform a randomized, double-blind controlled, prospective study in Advanced Pulmonary Adenocarcinoma patients with stage Ⅲa～Ⅳ. Patients are randomized over observational group (TCM granules plus first-line targeted therapy and TCM granules plus second-line targeted therapy ), and control group (TCM placebo plus first-line targeted therapy and TCM placebo plus second-line targeted therapy). The investigators will observe 6 months and after that regular follow-up will be arranged. The primary efficacy assessments are: PFS (progression-free survival）; Secondary efficacy assessments are: (1) OS(overall survival); (2) Objective response rate; (3) TTP（Time-to-Progression）; (4) QOL (Functional Assessment of Cancertherapy-lung, FACT-L4.0 scales;Lung Cancer Symptom Scale,LCSS); (5)other efficacy assessments are: 1) TCM symptoms changes; 2) Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect 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. Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
- Conditions
- Cancer
- Being tested
- TCM, EGFR-TKI
- Keywords
- lung cancer, traditional Chinese medicine, EGFR-TKI
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCMDrug
Also called YangYinFang:four packages twice a day, YiQiFang :four packages twice a day, YiQiYangYinFang:four packages twice a day
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.
EGFR-TKIDrug
Also called 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
Erlotinib 150 mg oral once a day or Gefitinib 250 mg oral once a day or Icotinib 125 mg oral three times a day
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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; Receives: Drug: EGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Measured: 2 months
Secondary outcomes (4)
Overall response rate(ORR)
Measured: 2 months
overall survival(OS)
Measured: 2 months
Time-to-Progression(TTP)
Measured: 2 months
quality of life(QOL),
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Chest Hospital
- Responsible party
- Principal investigator, Ling Xu, Shanghai University of Traditional Chinese Medicine
- Investigators
- Ling Xu, MD & PhD, Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745302
- Sponsor's protocol ID
- LH126
- Status last verified
- Jul 2016
- First submitted
- 22 Nov 2012
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 31333456
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma: a Randomized Double-blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01745302
- Acronym / sponsor ID
- LH126
- Conditions
- Cancer
- Keywords
- lung cancer, traditional Chinese medicine, EGFR-TKI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital
- Study start
- Nov 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At present, the third generation of platinum-based regimens (NCCN clinical practice guidelines recommended the use of vinorelbine or gemcitabine, or Taxol, etc.) is the first-line treatment for advanced lung cancer patients. Its effective rate is 20-30%, the median survival time is 7-9 months, 1-year and 2-year survival rate is 31-36% and 10-13% respectively. The efficacy has reached the platform and it is difficult to have more breakthroughs. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) such as Iressa and Erlotinib have proved effective in first or second line therapy for advanced non-small cell lung cancer(NSCLC).First-SIGNAL and IPASS research have laid first-line status for gefitinib in treatment of NSCLC and the progression-free survival time was maintained at 9-10 months. EGFR-TKIs treatment is simple, well tolerated, drug side effects, etc. There are also a rash, diarrhea and other adverse reactions, affecting the quality of life of patients with serious or even give patients a great deal of pain.Literature and our preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival time and improve quality of life QOL, but high-level evidences are needed.
The investigators perform a randomized, double-blind controlled, prospective study in Advanced Pulmonary Adenocarcinoma patients with stage Ⅲa～Ⅳ. Patients are randomized over observational group (TCM granules plus first-line targeted therapy and TCM granules plus second-line targeted therapy ), and control group (TCM placebo plus first-line targeted therapy and TCM placebo plus second-line targeted therapy). The investigators will observe 6 months and after that regular follow-up will be arranged. The primary efficacy assessments are: PFS (progression-free survival）; Secondary efficacy assessments are: (1) OS(overall survival); (2) Objective response rate; (3) TTP（Time-to-Progression）; (4) QOL (Functional Assessment of Cancertherapy-lung, FACT-L4.0 scales;Lung Cancer Symptom Scale,LCSS); (5)other efficacy assessments are: 1) TCM symptoms changes; 2) Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect 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. Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM plus EGFR-TKIs | – | Drug: TCM, Drug: EGFR-TKITCM: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; |
| Placebo plus EGFR-TKIs | – | Drug: EGFR-TKITCM 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; |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCMAlso: YangYinFang:four packages twice a day, YiQiFang :four packages twice a day, YiQiYangYinFang:four packages twice a dayTCM: 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. | Drug | TCM plus EGFR-TKIs |
| EGFR-TKIAlso: Erlotinib:150 mg oral, once a day,Tarceva, Gefitinib:250 mg oral, once a day,Iressa, Icotinib:125 mg oral,three times a day,ConmanaErlotinib 150 mg oral once a day or Gefitinib 250 mg oral once a day or Icotinib 125 mg oral three times a day | Drug | Placebo plus EGFR-TKIs, TCM plus EGFR-TKIs |
Primary outcome
Progression-free survival(PFS)
Time frame: 2 months
4 secondary outcomes
Overall response rate(ORR)
Time frame: 2 months
overall survival(OS)
Time frame: 2 months
Time-to-Progression(TTP)
Time frame: 2 months
quality of life(QOL),
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Derived from this study: PubMed 31333456Jiao 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Xu, MD & PhD principal investigator
Longhua Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Shanghai University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.