CancerPhase 2/3TCMNCT02777788
Curative Study of Chinese Traditional Medicine to Treat Lung Cancer
A Phase 2/3 study testing JinFuKang, XingZaoRuanJian and pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin in people with Cancer, run by Shanghai University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- JinFuKang, XingZaoRuanJian and pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2019
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan
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.
Read the 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:
- progression-free survival(PFS);
- overall survival(OS);
- Time to Progression (TTP);
- quality of life questionnaire（QOL);
- 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.
- Conditions
- Cancer
- Being tested
- JinFuKang, XingZaoRuanJian, pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin
- Keywords
- Chinese Traditional Medicine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JinFuKangDrug
Also called JinFuKang oral liquid
treated with chemotherapy
XingZaoRuanJianDrug
Also called RuanHuaTang
treated with chemotherapy
pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: JinFuKang; Drug: XingZaoRuanJian |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: up to 2 months
Time-to-Progression
Measured: up to 2 months
Number of participants with treatment-related quality of life as assessed by FACT-L4.0
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HEGEN LI, Study director, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777788
- Sponsor's protocol ID
- ZY3-CCCX-3-3023
- Acronym
- TCM
- Status last verified
- May 2017
- First submitted
- 9 May 2016
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan
- ClinicalTrials.gov ID
- NCT02777788
- Acronym / sponsor ID
- TCM / ZY3-CCCX-3-3023
- Conditions
- Cancer
- Keywords
- Chinese Traditional Medicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- Sep 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 May 2016 (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 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:
- progression-free survival(PFS);
- overall survival(OS);
- Time to Progression (TTP);
- quality of life questionnaire（QOL);
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Active comparator | Drug: pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatinEligible 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. |
| TCM combined chemotherapy | Experimental | Drug: JinFuKang, Drug: XingZaoRuanJianTCM：JinFuKang plus XingZaoRuanJian, chemotherapy will be the same. JinFuKang po.tid.30ml d6-d21 XingZaoRuanJian po.tid.30ml d6-d21 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| JinFuKangAlso: JinFuKang oral liquidtreated with chemotherapy | Drug | TCM combined chemotherapy |
| XingZaoRuanJianAlso: RuanHuaTangtreated with chemotherapy | Drug | TCM combined chemotherapy |
| pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin | Drug | chemotherapy |
Primary outcome
Progression-Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months
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.
3 secondary outcomes
Objective response rate
Time frame: up to 2 months
Time-to-Progression
Time frame: up to 2 months
Number of participants with treatment-related quality of life as assessed by FACT-L4.0
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- 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.
HEGEN LI study director
Shanghai University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing JinFuKang, XingZaoRuanJian and pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin in people with 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 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: status not confirmed, as of the sponsor's last update on 10 Oct 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2017.