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Non-small Cell Lung CancerPhase 3NCT01441752

Efficacy Study of Integrated TCM Combined With Chemotherapy in Postoperative NSCLC Patients

A Phase 3 study testing TCM in people with Non-small Cell Lung Cancer, run by xuling at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators performed a multi-center, randomized, controlled, double-blind, prospective study on evaluating effect of chemotherapy combined with or without integrated TCM on quality of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
TCM
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
349 participants
Where
2 sitesChina
Study dates
Nov 2011to Mar 2015
Phase
Phase 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Meet the diagnostic criteria of primary bronchial lung cancer, and pathologically or cytologically confirmed of NSCLC (squamouscarcinoma, adenocarcinoma, adenosquamous carcinoma and large cell carcinoma) patients;
  • Age > 18 years old;
  • TCM syndromes are Yin deficiency, Qi deficiency, deficiency of both Qi and Yin, deficiency of both Spleen and Kidney;
  • Physical status score (ECOG PS) ≤ 2 scores;
  • Stage Ib ~ Ⅲb with complete resection, chemotherapy is performed in 6 weeks after resection, including tumor size > 2cm of stage Ia;
  • Blood routine: N > 1.5×109/L、PLT > 100×109/L, normal liver function and kidney function;
  • Voluntarily involved to clinical study and sign informed consent.

Who cannot join

  • Suffering from other primary malignant tumor in 5 years;
  • Incomplete resection or uncertain to take resection;
  • Serious disease of heart, liver, kidney with severe dysfunction;
  • Pregnancy or breast-feeding women;
  • Mental or cognitive disorders which would influence judgment of QOL in this study;
  • During or had adjuvant chemotherapy;
  • Being participating other drug trials;
  • Allergy to the drug in our study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • ShanghaiUTCM

    Shanghai, Shanghai Municipality, 200032

  • Xuling

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: State Administration of Traditional Chinese Medicine of Shanghai

The investigators performed a multi-center, randomized, controlled, double-blind, prospective study on evaluating effect of chemotherapy combined with or without integrated TCM on quality of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. The investigators plan to involve 600 cases for observation in 3 years (300 cases for each group), expecting that QOL of postoperative NSCLC patients can be improved by integrated TCM combined with chemotherapy compared to that by chemotherapy alone.

Read the detailed description

At present the high rate of recurrence and metastasis of postoperative non-small cell lung cancer (NSCLC) patients is one of the leading causes resulting in failure of treating lung cancer. More than 35% of postoperative lung cancer patients with stage I died in 5 years due to recurrence or metastasis; the 5-year survival rates of stage II, IIIa, IIIb were 31%, 17.9% and 11.7% respectively. The survival rate was improved by 5% with adjuvant chemotherapy after resection, so regimen consist of platinum-based two chemical medicines are commended as the adjuvant chemotherapy for treating postoperative NSCLC patients, but the toxicity and side effects of chemotherapy can decrease quality of life (QOL) of patients. Literature and our preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival and improve QOL, but high-level evidences are needed.

The investigators perform a randomized, double-blind study in NSCLC patients after complete resection with stage I-III. Patients are randomized over observational group (TCM granules plus chemotherapy), and control group (TCM placebo plus chemotherapy). The investigators will observe 4 treatment periods, after that the observational group will be treated for another 4 months with integrated TCM combined with western medicine treatment (oral TCM medicines plus TCM intravenous injections), and there is no intervene measures in control group. Regular follow-up will be arranged. The primary efficacy assessments are: QOL (QLQ-C30 scales); Secondary efficacy assessments are: (1) 2-year disease-free survival rate; (2) disease-free survival; other efficacy assessments are: (1) TCM symptoms changes; (2) tumor markers (CEA, CA-125 and CYFRA21-1) and so on. Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with Western medicine treatment has a better efficacy on improving QOL of patients, prolonging disease-free survival time than that of chemotherapy treatment. Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.

Being tested
TCM, placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCMDrug

    Also called Prescriptions from Professor Liu Jiaxiang

    three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.

  • placeboDrug

    three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe，with the same color, smell ，taste weight and package

Study groups in NCT01441752
Study groupRoleWhat they receive
Chemotherapy + TCM groupExperimentalThe chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles. Prescriptions formulated into granules origin from Professor Liu Jiaxiang 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 . Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.
Receives: Drug: TCM
Chemotherapy + placebo groupPlacebo comparatorThe chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles.we compromise the raw materials for the placebo including 10% of Chinese medicine, food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. quality of life（QoL)

    Measured: every three weeks

Secondary outcomes (1)

  1. two-year disease-free survival rate and disease-free survival

    Measured: once every three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01441752
Sponsor's protocol ID
LC 001
Status last verified
Jun 2016
First submitted
14 Jul 2011
Last updated
27 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang Y, Jiao L, Chen Z, Xu J, Che J, Huang H, Zhang L, Shen X, Yang Y, Zhao T, Zhang J, Zhou D, Wang Q, Yao J, Yang W, Sun C, Li J, Bi L, Ding R, Goodfellow I, Gong Y, Xu L. Adjuvant Chemotherapy with Traditional Chinese Herbal Granules Versus Placebo in Resected Non-Small Cell Lung Cancer: Updated Survival Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251409081. doi: 10.1177/15347354251409081. Epub 2026 Jan 27.

    PubMed 41589575

  • Wang Q, Jiao L, Wang S, Chen P, Bi L, Zhou D, Yao J, Li J, Wang L, Chen Z, Jia Y, Zhang Z, Shen W, Zhu W, Xu J, Gao Y, Xu L, Gong Y. Adjuvant Chemotherapy with Chinese Herbal Medicine Formulas Versus Placebo in Patients with Lung Adenocarcinoma after Radical Surgery: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Biol Proced Online. 2020 Mar 1;22:5. doi: 10.1186/s12575-020-00117-5. eCollection 2020.

    PubMed 32140080

  • Xu L, Li H, Xu Z, Wang Z, Liu L, Tian J, Sun J, Zhou L, Yao Y, Jiao L, Su W, Guo H, Chen P, Liu J. Multi-center randomized double-blind controlled clinical study of chemotherapy combined with or without traditional Chinese medicine on quality of life of postoperative non-small cell lung cancer patients. BMC Complement Altern Med. 2012 Aug 1;12:112. doi: 10.1186/1472-6882-12-112.

    PubMed 22853619

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TCM in people with Non-small Cell Lung Cancer, run by xuling at 2 sites 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 7 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 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

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?

quality of life（QoL) (time frame: every three weeks). 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 NCT01441752, which also lists 3 linked publications.

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 27 Jun 2016.

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