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Gastric CancerPhase 3NCT02736552

Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.

A Phase 3 study testing S-1 for 6 months and S-1 for 1 year in people with Gastric Cancer, run by Fudan University at 10 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study aims to compare the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer. Hypothesis: For gastric patients after D2 resection, S-1 for 6 months shows non-inferiority to S-1 for 1 year in disease free survival(DFS), overall… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
S-1 for 6 months and S-1 for 1 year
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
10 sitesChina
Study dates
Mar 2016to Mar 2023
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Lower age limit of research subjects 18 years old and upper age limit of 75 years old.
  • Be proven to be primary adenocarcinoma of gastric cancer and staged II，IIIA or IIIB by pathological evidences
  • R0 surgery with lymphadenectomy
  • Without any other malignancies
  • ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
  • No contraindications to chemotherapy, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L).

Who cannot join

  • Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy.
  • Patients with stage I, IIIC and IV.
  • Unavailable for R0 resection and D2 lymph node dissection.
  • Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection.
  • With severe heart disease, including: congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension.
  • Any Known or suspected history of drug allergy test.
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  • The researchers believe the patient is not able to complete the entire course of the experiment.
  • Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy.
  • Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Anqing Municipal Hospital

    Anqing, Anhui

  • Cancer Center of Sun Yat-sen University

    Guangzhou, Guangdong

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong

  • Yuebei People's Hospital

    Guangzhou, Guangdong

  • Anhui Provincial Hospital

    Hefei, Anhui

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Lishui hospital of Zhejiang University

    Lishui, Zhejiang

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui

Other trials in China

About this study

Official title: A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.

The study aims to compare the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

Hypothesis: For gastric patients after D2 resection, S-1 for 6 months shows non-inferiority to S-1 for 1 year in disease free survival(DFS), overall survival (OS) and safety.

Read the detailed description

It has been identified that S-1 is an effective adjuvant treatment for East Asian patients who have undergone a D2 dissection for locally advanced gastric cancer（GC) in the Japanese Adjuvant Chemotherapy Trial of TS-1（S-1) for Gastric Cancer (ACTS-GC) trail , And S-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve equally or even more to overall survival(OS) and disease free survival(DFS) than S-1 for 1 year compared with S-1 for 6 months. As a result , An further clinical trail is still needed, This trial is designed to investigate the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

In this study, patients histologically confirmed stage II, IIIA or IIIB and who received D2 resection were randomly assigned to receive S-1 for 6 months or S-1 for 1 year. Patients aged from 18 to 75 years and adequate organ function, are randomized 1:1 to S-1 for 6 months and S-1 for 1 year. Both are the 3-week recycle of S-1 (80-120mg per day) for 2 weeks ,followed by 1 week of rest. The primary end point is 3-year DFS, and secondary end point is 5-year OS and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.In summary, we hold the hypothesis that S-1 for 6 months is equally effective, safer, and easier to carry out. If possible, there will be a new adjuvant chemotherapy strategy for gastric cancer patients after D2 resection.

To ensure the quality of the study, two interim analyses will be planned at the half and the completion of the study respectively. The DATA and Safety Monitoring Committee will independently review the interim analysis and stop the study ahead of schedule if necessary. Furthermore, to improve the study progress and quality, the in-house interim monitoring will be performed.

Conditions
Gastric Cancer
Being tested
S-1 for 6 months, S-1 for 1 year
Keywords
Gastric cancer, Adjuvant chemotherapy, S-1, D2 resection
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • S-1 for 6 monthsDrug

    6 months S-1 after D2 resection

  • S-1 for 1 yearDrug

    1 year S-1 after D2 resection

Study groups in NCT02736552
Study groupRoleWhat they receive
S-1 for 6 monthsExperimentalS-1 80-120mg daily for 14 days in 3 weeks for totally 6 months after D2 resection
Receives: Drug: S-1 for 6 months
S-1 for 1 yearActive comparatorS-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection
Receives: Drug: S-1 for 1 year

What is being measured

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

  1. Disease-free survival

    Measured: 3-year

Secondary outcomes (3)

  1. Overall survival

    Measured: 5-year

  2. Overall survival

    Measured: 3-year

  3. Side effects

    Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder.

    Measured: 12 months

Timeline

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

  1. First posted13 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2023 (estimated)

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
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02736552
Sponsor's protocol ID
CGCG001
Status last verified
May 2019
First submitted
4 Apr 2016
Last updated
8 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17.

    PubMed 22010012

  • 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

  • Tsuburaya A, Yoshida K, Kobayashi M, Yoshino S, Takahashi M, Takiguchi N, Tanabe K, Takahashi N, Imamura H, Tatsumoto N, Hara A, Nishikawa K, Fukushima R, Nozaki I, Kojima H, Miyashita Y, Oba K, Buyse M, Morita S, Sakamoto J. Sequential paclitaxel followed by tegafur and uracil (UFT) or S-1 versus UFT or S-1 monotherapy as adjuvant chemotherapy for T4a/b gastric cancer (SAMIT): a phase 3 factorial randomised controlled trial. Lancet Oncol. 2014 Jul;15(8):886-93. doi: 10.1016/S1470-2045(14)70025-7. Epub 2014 Jun 18.

    PubMed 24954805

  • O'Connell MJ, Laurie JA, Kahn M, Fitzgibbons RJ Jr, Erlichman C, Shepherd L, Moertel CG, Kocha WI, Pazdur R, Wieand HS, Rubin J, Vukov AM, Donohue JH, Krook JE, Figueredo A. Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol. 1998 Jan;16(1):295-300. doi: 10.1200/JCO.1998.16.1.295.

    PubMed 9440756

  • Chen S, Chen YB, Zhou ZW, Li W, Sun XW, Xu DZ, Li YF, Guan YX, Feng XY, Zhan YQ. No survival benefit from postoperative adjuvant chemotherapy after D2 radical resection for the patients with stage II gastric cancer. Am J Clin Oncol. 2011 Jun;34(3):309-13. doi: 10.1097/COC.0b013e3181dea94e.

    PubMed 20838324

  • Ji J, Liang H, Zhan Y, Liu Y, He Y, Ye Y, Sun Y, Huang C, Yan M, Shi Y, Wu A. [Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): Chinese subgroup analysis]. Zhonghua Wei Chang Wai Ke Za Zhi. 2014 Feb;17(2):133-8. Chinese.

    PubMed 24577767

  • Qu JL, Li X, Qu XJ, Zhu ZT, Zhou LZ, Teng YE, Zhang JD, Jin B, Zhao MF, Yu P, Liu YP. Optimal duration of fluorouracil-based adjuvant chemotherapy for patients with resectable gastric cancer. PLoS One. 2013 Dec 26;8(12):e83196. doi: 10.1371/journal.pone.0083196. eCollection 2013.

    PubMed 24386161

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing S-1 for 6 months and S-1 for 1 year in people with Gastric Cancer, run by Fudan University at 10 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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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. 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 was withdrawn before enrolling participants, so there are no results.

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?

Disease-free survival (time frame: 3-year). 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 NCT02736552, which also lists 7 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 8 May 2019.

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