CancerNCT01780181
Clinical Study of Chemotherapy Combined With Chinese Medicine on Survival Affect of Elderly Patients With Lung Cancer
An observational study of Cancer, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to observe the efficacy of chemotherapy combined with Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- TCM and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Sep 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Pathologically or cytologically confirmed of stage IIIb-IV NSCLC； Ages Eligible for Study: ≥65 years old; 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 IIIb-IV NSCLC ;
- Ages Eligible for Study: ≥65 years old;
- Physical status score (ECOG PS) ≤ 2 scores;
- Estimated life expectancy of at least 12 weeks;
- Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥9g/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.
- Patients who have received single-agent chemotherapy treatment；
- Estimated life expectancy less than 12 weeks;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-blind Controlled Clinical Study of Chemotherapy Combined With or Without Traditional Chinese Medicine on Survival Affect of Elderly Patients With Advanced Non-small-cell Lung Cancer
The purpose of this study is to observe the efficacy of chemotherapy combined with Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.
Read the detailed description
Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer diagnoses and more than 75% of the patients are diagnosed with an advanced stage. ASCO guidelines recommended that elderly patients with advanced NSCLC use single-agent chemotherapy. Nearly a decade of clinical trials showed that:the median survival time (MST) of Vinorelbine is 5-10months,1-year survival rate is 32%;the MST of Gemcitabine is 6.8-9months,the MST of Taxol is 6.8-10.3months.Research had shown that TCM can prolong long-term survival and improve QOL, but high-level evidence is desperately needed to support this finding.
The investigators perform a multi-center, randomized, double-blind controlled, prospective study in elderly patients with advanced NSCLC. Patients are randomized over observational group (TCM granules plus single-agent chemotherapy), and control group (TCM placebo plus single-agent chemotherapy). The investigators will observe 4 cycles and after that regular follow-up will be arranged. The primary end point is: PFS (progression-free survival); the secondary end points are: (1) OS(overall survival); (2) Objective response rate; (3) TTP(Time-to-Progression); (4) QOL (EORTC QLQ-L43, TCM syndrome score); (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 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.
- Conditions
- Cancer
- Being tested
- TCM, Chemotherapy
- Keywords
- lung cancer, traditional Chinese medicine
- 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.
ChemotherapyDrug
Also called treated with single-agent chemotherapy :, DOC：Docetaxel, NVB：Vinorelbine, GEM：Gemcitabine
treated with single-agent chemotherapy :DOC、NVB、GEM DOC 60mg/m2 d1 Q3W NVB 30mg/m2 d1，d8 Q3W GEM 1200mg/m2 d1，d8 Q3W
| Study group | Role | What they receive |
|---|---|---|
| TCM plus chemotherapy | TCM:oral granules,YangYinFang or YiQiFang or YiQiYangYinFang, four packages,twice a day, three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo; Receives: Drug: TCM; Drug: Chemotherapy | |
| Placebo plus chemotherapy | TCM Placebo: oral granules,YangYinFang orYiQiFang or YiQiYangYinFang, 10% of the original dose,four packages,twice a day ,three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo; Receives: Drug: Chemotherapy |
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 survival
Measured: 2 months
Objective response rate
Measured: 2 months
Time-to-Progression(TTP)
Measured: 2 months
quality of life(QOL)
Measured: one cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2016
- Study completionSep 2016
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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Chest Hospital, Fudan University
- Responsible party
- Principal investigator, Zhiyi Zhou, Shanghai University of Traditional Chinese Medicine
- Investigators
- Zhiyi Zhou, CMD, PhD, Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780181
- Sponsor's protocol ID
- 12401905700zzy
- Status last verified
- Oct 2016
- First submitted
- 29 Jan 2013
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhou ZY, Xu L, Li HG, Tian JH, Jiao LJ, You SF, Han ZF, Jiang Y, Guo HR, Liu H. Chemotherapy in conjunction with traditional Chinese medicine for survival of elderly patients with advanced non-small-cell lung cancer: protocol for a randomized double-blind controlled trial. J Integr Med. 2014 May;12(3):175-81. doi: 10.1016/S2095-4964(14)60028-5.
PubMed 24861837
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Controlled Clinical Study of Chemotherapy Combined With or Without Traditional Chinese Medicine on Survival Affect of Elderly Patients With Advanced Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01780181
- Acronym / sponsor ID
- 12401905700zzy
- Conditions
- Cancer
- Keywords
- lung cancer, traditional Chinese medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital, Fudan University
- Study start
- Dec 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Jan 2013 (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 purpose of this study is to observe the efficacy of chemotherapy combined with Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.
Detailed description
Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer diagnoses and more than 75% of the patients are diagnosed with an advanced stage. ASCO guidelines recommended that elderly patients with advanced NSCLC use single-agent chemotherapy. Nearly a decade of clinical trials showed that:the median survival time (MST) of Vinorelbine is 5-10months,1-year survival rate is 32%;the MST of Gemcitabine is 6.8-9months,the MST of Taxol is 6.8-10.3months.Research had shown that TCM can prolong long-term survival and improve QOL, but high-level evidence is desperately needed to support this finding.
The investigators perform a multi-center, randomized, double-blind controlled, prospective study in elderly patients with advanced NSCLC. Patients are randomized over observational group (TCM granules plus single-agent chemotherapy), and control group (TCM placebo plus single-agent chemotherapy). The investigators will observe 4 cycles and after that regular follow-up will be arranged. The primary end point is: PFS (progression-free survival); the secondary end points are: (1) OS(overall survival); (2) Objective response rate; (3) TTP(Time-to-Progression); (4) QOL (EORTC QLQ-L43, TCM syndrome score); (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM plus chemotherapy | – | Drug: TCM, Drug: ChemotherapyTCM:oral granules,YangYinFang or YiQiFang or YiQiYangYinFang, four packages,twice a day, three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo; |
| Placebo plus chemotherapy | – | Drug: ChemotherapyTCM Placebo: oral granules,YangYinFang orYiQiFang or YiQiYangYinFang, 10% of the original dose,four packages,twice a day ,three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo; |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Pathologically or cytologically confirmed of stage IIIb-IV NSCLC； Ages Eligible for Study: ≥65 years old; TCM syndromes are deficiency of Yin, deficiency of Qi and deficiency of both Qi and Yin.
Key inclusion criteria (6 listed)
- Pathologically or cytologically confirmed of stage IIIb-IV NSCLC ;
- Ages Eligible for Study: ≥65 years old;
- Physical status score (ECOG PS) ≤ 2 scores;
- Estimated life expectancy of at least 12 weeks;
- Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥9g/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;
Key exclusion criteria (8 listed)
- Patient with other malignant tumor except NSCLC 5 years previous to study entry.
- Patients who have received single-agent chemotherapy treatment；
- Estimated life expectancy less than 12 weeks;
- Serious problem of heart, liver or kidney with severe dysfunction;
- Pregnant or child breast feeding women;
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 chemotherapy |
| ChemotherapyAlso: treated with single-agent chemotherapy :, DOC：Docetaxel, NVB：Vinorelbine, GEM：Gemcitabinetreated with single-agent chemotherapy :DOC、NVB、GEM DOC 60mg/m2 d1 Q3W NVB 30mg/m2 d1，d8 Q3W GEM 1200mg/m2 d1，d8 Q3W | Drug | Placebo plus chemotherapy, TCM plus chemotherapy |
Primary outcome
Progression-free survival（PFS）
Time frame: 2 months
4 secondary outcomes
overall survival
Time frame: 2 months
Objective response rate
Time frame: 2 months
Time-to-Progression(TTP)
Time frame: 2 months
quality of life(QOL)
Time frame: one cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Derived from this study: PubMed 24861837Zhou ZY, Xu L, Li HG, Tian JH, Jiao LJ, You SF, Han ZF, Jiang Y, Guo HR, Liu H. Chemotherapy in conjunction with traditional Chinese medicine for survival of elderly patients with advanced non-small-cell lung cancer: protocol for a randomized double-blind controlled trial. J Integr Med. 2014 May;12(3):175-81. doi: 10.1016/S2095-4964(14)60028-5.
- Individual participant dataSharing planned: No
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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.
Zhiyi Zhou, CMD, PhD principal investigator
Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT01780181, 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 18 Oct 2016.