Gastric CancerPhase 2/3NCT02817425
A Efficacy and Tolerability Study of TEGAFOX Sequential S-1 in the Treatment of Adjuvant Chemotherapy for Gastric Cancer
A Phase 2/3 study testing SOX Sequential S-1, SOX and TEGAFOX Sequential S-1. in people with Gastric Cancer, run by LanZhou University at 1 site in China.
Trial summary
This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better. 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?
- SOX Sequential S-1, SOX and TEGAFOX Sequential S-1.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2013to May 2019
- 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
- 75≧Age≧18
- Histologically or cytologically confirmed gastrointestinal cancer
- Stage Ⅱ or Ⅲ or Ⅳ
- ECOG ≦2
- Accept the gastric cancer radical resection
- Life expectancy of at least three months
- Written informed consent to participate in the trial
Who cannot join
- History of severe hypersensitivity reactions to the ingredients of S-1\TF\5-FU/calcium folinate or oxaliplatin
- Inadequate hematopoietic function which is defined as below:
- white blood cell (WBC) less than 5x10^9/L
- absolute neutrophil count (ANC) less than 2x10^9/L
- platelets less than 100*10^9/L
- Inadequate hepatic or renal function which is defined as below:
Show all 15Show fewer
- serum bilirubin greater than 2 times the upper limit of normal range
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
- blood creatinine level greater than 2 times ULN
- Presence of peripheral neuropathy
- Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
- Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
- Psychiatric disorder or symptom that makes participation of the patient difficult;
- Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months
- Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Hospital Affiliated to Lanzhou University
Lanzhou, Gansu, 0931
WEN QIU, 0931-8487117, qiuwenmm@sina.com
XIAO CHEN, Professor
About this study
Official title: A Efficacy and Tolerability Study of Uracil/Ftorafur/Leucovorin Combined With Oxaliplatin (TEGAFOX) Sequential S-1 or SOX Sequential S-1 and S-1 Monotherapy in the Treatment of Adjuvant Chemotherapy for Gastric Cancer
This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.
- Conditions
- Gastric Cancer
- Being tested
- SOX Sequential S-1, SOX, TEGAFOX Sequential S-1.
- Keywords
- S-1, Adjuvant Chemotherapy, TEGAFOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOX Sequential S-1Drug
8 cycles SOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1.Every 21 days as a cycle.
SOXDrug
S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. Every 21 days as a cycle
TEGAFOX Sequential S-1.Drug
6 cycles TEGAFOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. TF 1000 mg/m2 with calcium folinate 300 mg/m2 IV infusion from Day 1 to Day 5 Every 28 days as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| SOX Sequential S-1 Group | Active comparator | Patients received chemotherapy with" oxaliplatin+ S-1 " for 6 months and sequential "S-1" for 6 months Receives: Drug: SOX Sequential S-1 |
| SOX Group | Active comparator | Patients received chemotherapy with" oxaliplatin+ S-1 " for 12 months Receives: Drug: SOX |
| TEGAFOX Sequential S-1 | Experimental | Patients received chemotherapy with" TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium) " for 6 months and sequential "S-1" for 6 months Receives: Drug: TEGAFOX Sequential S-1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survial (OS)
Measured: Event driven, an expected average of 48 months
Secondary outcomes (3)
Disease Free Survial
Measured: Event driven, an expected average of 24 months
Safety (Adverse Events)
Measured: Adverse events will be assessed at baseline (after the patients provided signed Informed Consent Form) until at least 4 weeks after the last dose of study drug was administered, an expected average of 3week
Dose intensity
Dose intensity will be used for present patients' compliance
Measured: Event driven, an expected average of 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMay 2013
- Primary completionApr 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Chen, MD, LanZhou University
- Investigators
- Xiao Chen, MD, Principal investigator, Second Hospital Affiliated to Lanzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817425
- Sponsor's protocol ID
- 2013078
- Status last verified
- Jun 2016
- First submitted
- 8 Jun 2015
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Efficacy and Tolerability Study of Uracil/Ftorafur/Leucovorin Combined With Oxaliplatin (TEGAFOX) Sequential S-1 or SOX Sequential S-1 and S-1 Monotherapy in the Treatment of Adjuvant Chemotherapy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT02817425
- Acronym / sponsor ID
- 2013078
- Conditions
- Gastric Cancer
- Keywords
- S-1, Adjuvant Chemotherapy, TEGAFOX
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SOX Sequential S-1 Group | Active comparator | Drug: SOX Sequential S-1Patients received chemotherapy with" oxaliplatin+ S-1 " for 6 months and sequential "S-1" for 6 months |
| SOX Group | Active comparator | Drug: SOXPatients received chemotherapy with" oxaliplatin+ S-1 " for 12 months |
| TEGAFOX Sequential S-1 | Experimental | Drug: TEGAFOX Sequential S-1.Patients received chemotherapy with" TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium) " for 6 months and sequential "S-1" for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 75≧Age≧18
- Histologically or cytologically confirmed gastrointestinal cancer
- Stage Ⅱ or Ⅲ or Ⅳ
- ECOG ≦2
- Accept the gastric cancer radical resection
Key exclusion criteria (15 listed)
- History of severe hypersensitivity reactions to the ingredients of S-1\TF\5-FU/calcium folinate or oxaliplatin
- Inadequate hematopoietic function which is defined as below:
- Inadequate hepatic or renal function which is defined as below:
- Presence of peripheral neuropathy
- Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOX Sequential S-18 cycles SOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1.Every 21 days as a cycle. | Drug | SOX Sequential S-1 Group |
| SOXS-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. Every 21 days as a cycle | Drug | SOX Group |
| TEGAFOX Sequential S-1.6 cycles TEGAFOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. TF 1000 mg/m2 with calcium folinate 300 mg/m2 IV infusion from Day 1 to Day 5 Every 28 days as a cycle. | Drug | TEGAFOX Sequential S-1 |
Primary outcome
Overall Survial (OS)
Time frame: Event driven, an expected average of 48 months
3 secondary outcomes
Disease Free Survial
Time frame: Event driven, an expected average of 24 months
Safety (Adverse Events)
Time frame: Adverse events will be assessed at baseline (after the patients provided signed Informed Consent Form) until at least 4 weeks after the last dose of study drug was administered, an expected average of 3week
Dose intensity
Time frame: Event driven, an expected average of 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Chen, MD principal investigator
Second Hospital Affiliated to Lanzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SOX Sequential S-1, SOX and TEGAFOX Sequential S-1. in people with Gastric Cancer, run by LanZhou 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 7 inclusion and 15 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 29 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Chen, MD (+86 0931-8942318, chenxiaomd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survial (OS) (time frame: Event driven, an expected average of 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2016; AzTrials last refreshed its copy on 1 Nov 2026.