AzTrials
AzTrials

Gastric CancerPhase 2/3NCT01516944

Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

A Phase 2/3 study testing Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin and Oxaliplatin; Capecitabine in people with Gastric Cancer, run by Hebei Medical University 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

Stage I：Neoadjuvant therapy Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin Stage II: Perioperative therapy Perioperative Tegafur，Gimeracil and Oteracil… 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?
Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin and Oxaliplatin; Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
749 participants
Where
1 siteChina
Study dates
Feb 2012to Dec 2018
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

  • Age 18 -75
  • Histologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction)
  • ECOG performance status ≦2
  • Tumor stage T3/4NxM0
  • No distant metastasis (M0)

Who cannot join

  • History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
  • Inadequate hematopoietic function： WBC≦4,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3
  • Inadequate organ function which is defined as below:
  • Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
  • Symptomatic peripheral neuropathy
  • Receiving a concomitant treatment with other fluoropyrimidines
Show all 11Show fewer
  • Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method.
  • Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication:
  • Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
  • History of ventricular arrhythmia or congestive heart failure.
  • Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of General Surgery

    Shijiazhuang, Hebei, 050011

Other trials in China

About this study

Official title: Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer

Stage I：Neoadjuvant therapy

  • Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin
Read more

Stage II: Perioperative therapy

  • Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin
  • A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer.
Conditions
Gastric Cancer
Being tested
Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin, Oxaliplatin; Capecitabine
Keywords
Tegafur，Gimeracil and Oteracil Potassium Capsules, Capecitabine, Oxaliplatin, perioperative Chemotherapy, Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Tegafur, Gimeracil and Oteracil Potassium Capsules；OxaliplatinDrug

    Also called S-1, Oxaliplatin

    Tegafur，Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation

  • Tegafur, Gimeracil and Oteracil Potassium Capsules；OxaliplatinDrug

    Also called S-1, Oxaliplatin

    Tegafur，Gimeracil and Oteracil Potassium Capsules 80mg/㎡ ,D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycles preoperation, Tegafur，Gimeracil and Oteracil Potassium Capsules ,80 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for six cycles postoperation

  • Oxaliplatin; CapecitabineDrug

    Also called Oxaliplatin, Capecitabine

    Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycle pre-operation, Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/m2 D1 q3wk for six cycles postoperation

Study groups in NCT01516944
Study groupRoleWhat they receive
postoperative chemotherapy,SOXActive comparatorNot described
Receives: Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin
Perioperative chemotherapy,SOXExperimentalNot described
Receives: Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin
Perioperative chemotherapy,XELOXExperimentalNot described
Receives: Drug: Oxaliplatin; Capecitabine

What is being measured

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

  1. Disease-free survival(DFS)

    Measured: 3 year

Secondary outcomes (6)

  1. Objective response rate (ORR)

    Measured: At the end of the study

  2. Disease control rate (DCR)

    To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria

    Measured: At the end of the study

  3. Down staging rate

    After the pathological examination of resected specimen

    Measured: Within 3 weeks after surgery

  4. Overall survival (OS)

    Measured: 5 year

  5. Adverse events

    Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit.

    Measured: Side effects during observation

  6. R0-resection rate

    After the pathological examination of resected specimen

    Measured: Within 3 weeks after surgery

Timeline

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

  1. First posted25 Jan 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionApr 2018
  4. Study completionDec 2018

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
749 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516944
Sponsor's protocol ID
TOTTG030103
Status last verified
Feb 2020
First submitted
10 Jan 2012
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Ding P, Chen S, Guo H, Yang J, Fu Q, Wang B, Gu R, Zhang L, Wu J, Wu H, Meng N, Li X, Guo Z, Tian Y, Meng L, Zhao Q. Radiomics-based ensemble model predicts postoperative recurrence of gastric cancer. BMC Med. 2025 Nov 25;23(1):656. doi: 10.1186/s12916-025-04393-4.

    PubMed 41291636

  • Ding P, Wu J, Wu H, Sun C, Meng M, Lowe S, Tian Y, Guo H, Meng L, Zhao Q. Comment on 'Hand grip strength-based cachexia index as a predictor of cancer cachexia and prognosis in patients with cancer' by Xie et al. J Cachexia Sarcopenia Muscle. 2023 Oct;14(5):2449-2451. doi: 10.1002/jcsm.13298. Epub 2023 Jul 28. No abstract available.

    PubMed 37501640

  • Zhao Q, Lian C, Huo Z, Li M, Liu Y, Fan L, Tan B, Zhao X, Zhang Z, Wang D, Liu Y, Guo H, Yang P, Tian Y, Li Y. The efficacy and safety of neoadjuvant chemotherapy on patients with advanced gastric cancer: A multicenter randomized clinical trial. Cancer Med. 2020 Aug;9(16):5731-5745. doi: 10.1002/cam4.3224. Epub 2020 Jun 24.

    PubMed 32583567

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin and Oxaliplatin; Capecitabine in people with Gastric Cancer, run by Hebei Medical University 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 5 inclusion and 11 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 13 Feb 2020. 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?

Disease-free survival(DFS) (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 NCT01516944, 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 13 Feb 2020.

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