Gastric CancerPhase 2NCT01980407
Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer
A Phase 2 study testing S-1, leucovorin, oxaliplatin in people with Gastric Cancer, run by Jilin Provincial Tumor Hospital at 1 site in China.
Trial summary
In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1, leucovorin, oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- Histologically or cytologically documented gastric adenocarcinoma
- Performance status (ECOG scale): 0-2
- Life expectancy ≥ 3 months
- No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for adjuvant or neoadjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment.
- WIth Measurable Target lesion
- Patients should sign a written informed consent before study entry
Who cannot join
- History of hypersensitivity to fluoropyrimidines, S-1, oxaliplatin or the ingredients product
- Inadequate hematopoietic function: WBC≦5,000/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 > 2 upper limit of normal range (ULN);
- Symptomatic peripheral neuropathy ≥ NCI CTC AE grade 1;
- Receiving a concomitant treatment with other fluoropyrimidines or fluorocytosine;
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;
- History of ventricular arrhythmia or congestive heart failure;
- Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study;
- Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical, paralytic or poor control diabetes
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jilin Provincial Tumor Hospital
Changchun, Jilin
About this study
Official title: A Safety and Efficacy Study of S-1, Oxaliplatin, and Leucovorin (SOL) in Patients With Advanced Gastric Cancer
In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- S-1, leucovorin, oxaliplatin
- Keywords
- S-1, Oxaliplatin, Leucovorin, 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, leucovorin, oxaliplatinDrug
Also called S-1 (20mg):Taiho Pharmaceutical Co., Ltd.；, formyltetrahydrofolate (15mg), L-OHP (50mg)
S-1 (20mg), capsule, 40-60mg, bid, p.o., day1-14； Leucovorin (15 mg), tablet, 30mg,Bid, p.o., day1-14; Oxaliplatin (50 mg), injection 85mg/m2, day1.
| Study group | Role | What they receive |
|---|---|---|
| SOL, single arm | Experimental | S-1 combined with leucovorin and oxaliplatin Receives: Drug: S-1, leucovorin, oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Evaluate the objective response rate followed by RECIST 1.1.
Measured: 6-8 weeks
Secondary outcomes (4)
Adverse events
Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, The number of Participants with adverse events will be recorded at each treatment visit.
Measured: 1 year
Overall survival
Measured: 3 year
Progress free survival
Tumor assessment will be performed every 3 cycles (9 weeks) from the start of treatment until progression or as for the metastatic site developed during the study (including clinical suspicion). In order to confirm objective tumor response, additional confirmatory scan should be obtained at least 4 weeks following the first radiological evidence of tumor response.
Measured: up to 9 weeks
Disease control rate
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Measured: up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin Provincial Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Yue, Jilin Provincial Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980407
- Sponsor's protocol ID
- JPCH1301
- Other IDs
- TOTMS1311
- Status last verified
- Nov 2013
- First submitted
- 27 Oct 2013
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of S-1, Oxaliplatin, and Leucovorin (SOL) in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01980407
- Acronym / sponsor ID
- JPCH1301
- Conditions
- Gastric Cancer
- Keywords
- S-1, Oxaliplatin, Leucovorin, Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Jilin Provincial Tumor HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 11 Nov 2013 (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.
In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOL, single arm | Experimental | Drug: S-1, leucovorin, oxaliplatinS-1 combined with leucovorin and oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age over 18 years old
- Histologically or cytologically documented gastric adenocarcinoma
- Performance status (ECOG scale): 0-2
- Life expectancy ≥ 3 months
- No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
Key exclusion criteria (11 listed)
- History of hypersensitivity to fluoropyrimidines, S-1, oxaliplatin or the ingredients product
- Inadequate hematopoietic function: WBC≦5,000/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 > 2 upper limit of normal range (ULN);
- Symptomatic peripheral neuropathy ≥ NCI CTC AE grade 1;
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, leucovorin, oxaliplatinAlso: S-1 (20mg):Taiho Pharmaceutical Co., Ltd.；, formyltetrahydrofolate (15mg), L-OHP (50mg)S-1 (20mg), capsule, 40-60mg, bid, p.o., day1-14； Leucovorin (15 mg), tablet, 30mg,Bid, p.o., day1-14; Oxaliplatin (50 mg), injection 85mg/m2, day1. | Drug | SOL, single arm |
Primary outcome
Response rate
Time frame: 6-8 weeks
Evaluate the objective response rate followed by RECIST 1.1.
4 secondary outcomes
Adverse events
Time frame: 1 year
Overall survival
Time frame: 3 year
Progress free survival
Time frame: up to 9 weeks
Disease control rate
Time frame: up to 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
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, leucovorin, oxaliplatin in people with Gastric Cancer, run by Jilin Provincial Tumor Hospital 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 8 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 Mar 2015. 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 Yue Zhang, MD, Ph.D (+86-0431-85872596, JPCH2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 6-8 weeks). 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 5 Mar 2015.