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Gastric CancerPhase 3CAPITALNCT01795027

Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer

A Phase 3 study testing S-1 plus oxaliplatin and S-1 single in people with Gastric Cancer, run by Sun Yat-sen University at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer
What is being tested?
S-1 plus oxaliplatin and S-1 single
Could I receive a placebo?
No, everyone receives an active treatment
How many people
724 participants
Where
13 sitesChina
Study dates
Sep 2011to Jun 2018
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • informed consensus of patients
  • be able to receive oral administration
  • from 18 to 70 years old
  • be proven to be primary adenocarcinoma of gastric cancer and staged II or III by pathological evidences
  • without other chemotherapy and/or radiation against to the disease
  • normal function of other organs including heart,liver ,kidney and so on
  • Eastern Cooperative Oncology Group performance status:0~2

Who cannot join

  • history of other malignancy
  • allergic reaction to S-1 or oxaliplatin
  • be enrolling in other clinical trials
  • abnormal GI tract function
  • dysfunction of other organs
  • female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy
  • other situation to be judged not adaptive to the study by investigators

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • the central hospital of Chaozhou

    Chaozhou, Guangdong

  • the 1st people's hospital of Foshan

    Foshan, Guangdong

  • cancer center of Guangzhou medical college

    Guangzhou, Guangdong

  • cancer center of Sun yat-sen University

    Guangzhou, Guangdong

  • Guangdong Traditional Medical Hospital

    Guangzhou, Guangdong

  • the 1st affliated hospital of Guangdong pharmacuetic college

    Guangzhou, Guangdong

  • the 1St Affliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong

  • the 6th affliated hospital of Sun-yat-sen University

    Guangzhou, Guangdong

  • the 1st hospital of Shantou University

    Shantou, Guangdong

  • the cental hospital of Shantou

    Shantou, Guangdong

  • YUE-BEI people's hospital

    Shaoguan, Guangdong

  • the 2nd people's hospital of Shenzhen

    Shenzhen, Guangdong

  • the 5th hospital of Sun-yat-sen University

    Zhuhai, Guangdong

Other trials in China

About this study

Official title: A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer

Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

Patients and methods: In this study , patients with histologically confirmed gastric cancer who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40~60mg twice everyday for 14 days in a 21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end of the 1st year postoperatively(SOX) , or TS-1 single 40~60mg twice everyday for 14 days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.

Conditions
Gastric Cancer
Being tested
S-1 plus oxaliplatin, S-1 single
Keywords
gastric cancer, chemotherapy, D2 resection, S-1
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 plus oxaliplatinDrug

    Also called SOX

    6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection

  • S-1 singleDrug

    Also called S-1

    16 courses S-1 single after d D2 resection

Study groups in NCT01795027
Study groupRoleWhat they receive
S-1 plus OxaliplatinExperimental6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
Receives: Drug: S-1 plus oxaliplatin
S-1 singleActive comparatorS-1 40~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection
Receives: Drug: S-1 single

What is being measured

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

  1. overall survival

    Measured: 5 year

Secondary outcomes (2)

  1. disease-free survival

    Measured: 3 year

  2. Number of Participants with Adverse Events

    Measured: 5 year

Timeline

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

  1. First posted20 Feb 2013 (estimated)
  2. Study startSep 2011
  3. Primary completionNov 2016 (estimated)
  4. Study completionJun 2018 (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
724 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01795027
Sponsor's protocol ID
SYSUCCGPS
Other IDs
ZHOUZHIWEI
Acronym
CAPITAL
Status last verified
Oct 2016
First submitted
14 Feb 2013
Last updated
25 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Nie RC, Chen S, Wan J, Sun XW, Hong WQ, Wei HB, Wang W, Zhang WB, Zhao Y, Zhang WB, Chen JS, Wu ZG, Mai C, Feng CZ, Yuan SQ, Wang W, Qiu HB, Liang Y, Guan YX, Chen YM, Liu WW, Ding C, Peng JS, Chen YB, Zhou ZW, Li YF. Adjuvant oxaliplatin with S-1 (SOX) versus S-1 for stage II-III gastric cancer (CAPITAL): A randomized, open-label, phase 3 trial. Med. 2026 Aug 14:101258. doi: 10.1016/j.medj.2026.101258. Online ahead of print.

    PubMed 42600610

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing S-1 plus oxaliplatin and S-1 single in people with Gastric Cancer, run by Sun Yat-sen University at 13 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 7 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 25 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 13 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?

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?

overall survival (time frame: 5 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 NCT01795027, 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 25 Oct 2016.

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