S-1 Plus OxaliplatinPhase 2NCT04694404
Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer
A Phase 2 study testing S-1,Oxaliplatin in people with S-1 Plus Oxaliplatin, run by Aiping Zhou at 1 site in China.
Trial summary
Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- S-1 Plus Oxaliplatin
- What is being tested?
- S-1,Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2016to 1 Dec 2022
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma;
- Aged≥60
- ability of oral administration;
- CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1);
- Untreated
- more than 12 months after the last adjuvant/neoadjuvant chemotherapy;
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- ECOG=0-2;
- Available organ function: ALT≤2.5xULN;AST≤2.5xULN;If patients have hepaticmetastasis,ALT≤2.5xULN,AST≤2.5xULN;ALP≤2xULN;TBIL≤1.0xULN;NEUT≥1.5×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;Creatinine Clearance≥60ml/min
- Informed consent;
- Expected survival more than 3 months;More than 3 weeks after major surgery.
Who cannot join
- Neoadjuvant and/or adjuvant have been treated with more than two plans;
- In the past two years, the total dose of oxaliplatin≥800mg/m2;
- Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer;
- Symptomatic brain metastases or soft meningeal metastasis;
- Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure;
- Serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); Chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);Gastrointestinal bleeding requires regular blood transfusion;HIV or AIDS; Mental illness; Neuropathy grade≥2;Infectious diseases or inflammation, temperature≥38℃;
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- Known allergy to drugs in the study;
- Pregnant or lactating women;
- Both male and female subjects of potential fertility have to agree effective birth control during the entire study;
- Experimental drugs used no more than 4 weeks;
- Other conditions the researchers considered ineligible for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing, 100021
Aiping Zhou, Doctor, +86 13691161998, zhouap1825@126.com
Aiping Zhou, Doctor
About this study
Official title: The Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced or Recurrent Gastric Cancer
Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.
Read the detailed description
3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.
- Conditions
- S-1 Plus Oxaliplatin
- Being tested
- S-1,Oxaliplatin
- Keywords
- S-1,Oxaliplatin,Advanced or Recurrent 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.
S-1,OxaliplatinDrug
Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w)
| Study group | Role | What they receive |
|---|---|---|
| S-1 Plus Oxaliplatin | Experimental | Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w) Receives: Drug: S-1,Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: 6 months
Secondary outcomes (3)
ORR
Objective response rate
Measured: 6 months
OS
Overall survival
Measured: 1 year
The number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start11 May 2016
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for S-1 Plus OxaliplatinStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Eledrly Patients with Untreated Advanced or Recurrent Gastric Cancer
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aiping Zhou
- Responsible party
- Sponsor-investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Aiping Zhou, Doctor, Study director, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694404
- Sponsor's protocol ID
- CH-PI-105
- Status last verified
- Jan 2021
- First submitted
- 5 Nov 2017
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang Z, Zhou A, Sun Y, Zhang W. Biweekly oxaliplatin plus S1 for Chinese elderly patients with advanced gastric or gastroesophageal junction cancer as the first-line therapy: a single-arm, phase 2 study. BMC Cancer. 2022 Mar 9;22(1):253. doi: 10.1186/s12885-022-09332-7.
PubMed 35264150
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced or Recurrent Gastric Cancer
- ClinicalTrials.gov ID
- NCT04694404
- Acronym / sponsor ID
- CH-PI-105
- Conditions
- S-1 Plus Oxaliplatin
- Keywords
- S-1,Oxaliplatin,Advanced or Recurrent Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aiping Zhou
- Study start
- 11 May 2016 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- 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.
Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.
Detailed description
3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Eledrly Patients with Untreated Advanced or Recurrent Gastric Cancer
| Arm | Type | Receives |
|---|---|---|
| S-1 Plus Oxaliplatin | Experimental | Drug: S-1,OxaliplatinOxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma;
- Aged≥60
- ability of oral administration;
- CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1);
- Untreated
Key exclusion criteria (11 listed)
- Neoadjuvant and/or adjuvant have been treated with more than two plans;
- In the past two years, the total dose of oxaliplatin≥800mg/m2;
- Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer;
- Symptomatic brain metastases or soft meningeal metastasis;
- Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure;
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 |
|---|---|---|
| S-1,OxaliplatinOxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w) | Drug | S-1 Plus Oxaliplatin |
Primary outcome
PFS
Time frame: 6 months
Progression-free survival
3 secondary outcomes
ORR
Time frame: 6 months
OS
Time frame: 1 year
The number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 35264150Jiang Z, Zhou A, Sun Y, Zhang W. Biweekly oxaliplatin plus S1 for Chinese elderly patients with advanced gastric or gastroesophageal junction cancer as the first-line therapy: a single-arm, phase 2 study. BMC Cancer. 2022 Mar 9;22(1):253. doi: 10.1186/s12885-022-09332-7.
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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.
Aiping Zhou, Doctor study director
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1,Oxaliplatin in people with S-1 Plus Oxaliplatin, run by Aiping Zhou 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 10 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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 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.
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 Aiping Zhou, Doctor (+86 13691161998, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 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 NCT04694404, 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 5 Jan 2021.