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AzTrials

Gastric Cancer Stage IIIBPhase 2/3CHANGENCT03607656

The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer

A Phase 2/3 study testing Oxaliplatin, Capecitabine and TCM in people with Gastric Cancer Stage IIIB and Gastric Cancer Stage IIIC, run by Shanghai University of Traditional Chinese Medicine at 1 site 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

This is a randomized, open-label study done in 3 hospitals in China. Patients with stage IIIB and IIIC gastric cancer who undergo curative D2 gastrostomy will be randomly assigned after surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant chemotherapy combined Traditional Chinese… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Oxaliplatin, Capecitabine and TCM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteChina
Study dates
8 Jun 2018to 30 Nov 2023
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven gastric carcinoma with radical operation, TNM (primary tumor, regional nodes, metastasis) stage IIIb or IIIc （The Eighth Edition American Joint Committee on Cancer [AJCC] gastric cancer staging）;
  • Karnofsky performance status higher than 70;
  • Adequate hepatic, renal, cardio and hematologic function;
  • With patients' consent and comply to long term follow-up.

Who cannot join

  • Gastrectomy beyond D2, or TNM stage beyond Ⅲb and Ⅲc;
  • Histological type beyond gastric carcinoma;
  • Conversion chemotherapy before surgery;
  • Concurrent cancer;
  • Women of gravid or lactating; patients with mental illness;
  • Uncontrolled significant comorbid conditions.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Longhua Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer: A Randomized Controlled Trial

This is a randomized, open-label study done in 3 hospitals in China. Patients with stage IIIB and IIIC gastric cancer who undergo curative D2 gastrostomy will be randomly assigned after surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant chemotherapy combined Traditional Chinese treatment. The primary outcome was disease-free survival and 3-year disease-free survival rate in the intention-to-treat population.

Read the detailed description

The purpose of this study is to evaluate the Traditional Chinese Medicine combined adjuvant chemotherapy in the treatment of stage IIIb and IIIc gastric cancer through randomized controlled trial.

Metastasis and recurrence is the primary cause in decreasing the survival time of gastric cancer patients who experienced radical operation. Among whom, patients with stage IIIB and IIIC are especially in high risk of metastasis and recurrence, result in a significant poor survival time than patients with earlier stages.

Oxaliplatin with capecitabine is the standard adjuvant chemotherapy for curative D2 gastrostomy gastric cancer, contribute the 3-year disease free survival rate of 74% in ITT, and 61% in stage IIIB sub-group. Meanwhile, Traditional Chinese Medicine (TCM) treatment has been used for thousands of years in Chinese clinical practices. In China, the clinical curative effect of TCM in the treatment of gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the TCM is effective and safety for gastric cancer.In order to evaluate efficacy on TCM combined adjuvant chemotherapy in IIIB and IIIC gastric cancer, we design this randomized, open-label study.

Being tested
Oxaliplatin, Capecitabine, TCM, S-1, Docetaxel
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • OxaliplatinDrug

    Oxaliplatin powder injection

  • CapecitabineDrug

    Capecitabine tablet

  • TCMOther

    TCM decoction orally taken twice a day for at least 3 months

  • S-1Drug

    S-1 capsule

  • DocetaxelDrug

    Docetaxel injection

  • 5-FUDrug

    5-FU injection

Study groups in NCT03607656
Study groupRoleWhat they receive
TCM combines CapOX/SOX/S-1+D/FLOTExperimentalTraditional Chinese Medicine oral taken twice a day for at least 3 months combined with chemotherapy. The chemotherapy can choose intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21 days; or intravenous oxaliplatin 100 mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 40mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 50mg/m(2) on day 1 plus intravenous oxaliplatin 85 mg/m(2) on day 1 plus 5-FU intravenously CIV24h on day 1, every 14 days; Each participant shoud take eight (8) cycles of chemotherapy.
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Other: TCM; Drug: S-1; Drug: Docetaxel; Drug: 5-FU
CapOX/SOX/S-1+D/FLOTActive comparatorThe chemotherapy can choose intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21 days; or intravenous oxaliplatin 100 mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 40mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 50mg/m(2) on day 1 plus intravenous oxaliplatin 85 mg/m(2) on day 1 plus 5-FU intravenously CIV24h on day 1, every 14 days; Each participant shoud take eight (8) cycles of chemotherapy.
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1; Drug: Docetaxel; Drug: 5-FU

What is being measured

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

  1. 3-year Disease Free Survival rate

    The rate refers to cases that see first tumor metastasis or recurrence or death of any cause from randomization.

    Measured: 36 months

Secondary outcomes (2)

  1. Safety （adverse effects）

    Using NCI-CTC standard to record adverse effects of chemotherapy and treatments.

    Measured: 36 months

  2. EORTC QLQ-C30 scale

    Using the EORTC QLQ-C30 scale (European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30) to evaluate the quality of life of patients. The scale includes 14 aspects: physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial problem, with each aspect scores from one point to four points (lower points represent a better quality of life), and a general quality of life scores from one point to seven points (higher points represent a better quality of life).

    Measured: 36 months

Timeline

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

  1. First posted31 Jul 2018
  2. Study start8 Jun 2018
  3. Primary completion31 Oct 2022
  4. Study completion30 Nov 2023

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03607656
Sponsor's protocol ID
LONGHUA-2018-SH
Acronym
CHANGE
Status last verified
Dec 2023
First submitted
1 Jul 2018
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.

    PubMed 22226517

  • Xu Y, Zhao AG, Li ZY, Zhao G, Cai Y, Zhu XH, Cao ND, Yang JK, Zheng J, Gu Y, Han YY, Zhu YJ, Yang JZ, Gao F, Wang Q. Survival benefit of traditional Chinese herbal medicine (a herbal formula for invigorating spleen) for patients with advanced gastric cancer. Integr Cancer Ther. 2013 Sep;12(5):414-22. doi: 10.1177/1534735412450512. Epub 2012 Jul 9.

    PubMed 22781545

  • Li Z, Zhang G, Cao N, Xu J, Dong J, Li J, Zhu X, Xu Y, Han C, Wang R, Xia X, Zhao G, Huan X, Fan J, Zhao A. Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial. Trials. 2022 Jan 21;23(1):68. doi: 10.1186/s13063-022-06013-5.

    PubMed 35063002

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oxaliplatin, Capecitabine and TCM in people with Gastric Cancer Stage IIIB and Gastric Cancer Stage IIIC, 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 4 inclusion and 6 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 Dec 2023. 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.

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?

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?

3-year Disease Free Survival rate (time frame: 36 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 NCT03607656, 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 18 Dec 2023.

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