Recurrent Gastric CancerPhase 23GNCT01100801
A Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients
A Phase 2 study testing TS-1 with cisplatin and TS-1 with oxaliplatin in people with Recurrent Gastric Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This is an open, non-randomized, multicenter Phase II study evaluating cisplatin plus TS-1 or oxaliplatin plus TS-1 as first-line therapy in predicted 'responder' to platinum and fluoropyrimidine. This study is planned in 3 centers in Singapore and Korea. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Recurrent Gastric Cancer
- What is being tested?
- TS-1 with cisplatin and TS-1 with 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
- 90 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2010to Dec 2018
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented locally advanced, metastatic or recurrent gastric cancer for which convention therapy of a platinum/fluoropyrimidine combination is indicated
- Predicted 'responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in-vitro sensitivity array
- At least one measurable defined by RECIST
- Age >=21 years old
- Performance status (ECOG) 0-2
- Life expectancy >3 months
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- No significant problems for oral intake and drug administration
- Adequate organ functions:
- bone marrow function (ANC = 1,500/uL, Platelet = 100,000/ uL, Hb = 8.0 g/dl) renal function: serum creatinine = UNL (if serum creatinine > ULN, creatinine clearance should be = 60 mL/min) hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x ULN without liver metastasis, total bilirubin < 3x ULN and AST/ALT levels < 5 x ULN with liver metastasis)
- Recovery from relevant toxicity to previous treatment before study entry
- Ability to understand and willingness to sign a written informed consent before study entry
Who cannot join
- Prior chemotherapy for gastric cancer except neoadjuvant or adjuvant systemic therapy if terminated at least 6 months before the start of treatment in this study
- Prior radiotherapy was administered to target lesions selected for this study
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- Presence of symptomatic or progressing CNS metastasis
- Serious illness or medical conditions:
- Congestive heart failure (NYHA class III or IV), unstable angina or myocardial infarction within the past 3 months Hepatic cirrhosis (= Child class B) Psychiatric disorder that may interfere with protocol compliance Active infection
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- Known hypersensitivity to platinum or fluoropyrimidine.
- Pregnant or lactating woman. Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
- Predicted 'non-responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in- vitro sensitivity array
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, Singapore
Wei Peng Yong, MRCP, MB ChB, 65 6772 4670, Wei_Peng_Yong@nuhs.edu.sg
About this study
Official title: A Phase II Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients
This is an open, non-randomized, multicenter Phase II study evaluating cisplatin plus TS-1 or oxaliplatin plus TS-1 as first-line therapy in predicted 'responder' to platinum and fluoropyrimidine.
This study is planned in 3 centers in Singapore and Korea. A total of 30 subjects will be enrolled into each treatment arms. Each centers will recruit 15-25 subjects predicted to be 'responder' to platinum and fluoropyrimidine. The study will consist of a prescreening period, a screening period and a treatment period. A fresh tumour biopsy sample will be obtained during the prescreening period for gene expression profiling.
Read more
As this is a genomics guided trial, obtaining tissue biopsies is vital to the conduct of the trial.
Patients will have the primary in situ (requirement for entry into trial), endoscopic biopsy performed prior to 1st cycle.
Read the detailed description
Gastric cancer is the world's second leading cause of cancer death. For patients with unresectable disease or recurrent disease after surgery, the main therapeutic option is chemotherapy. Chemotherapy can improve survival and quality of life in patients with advanced disease when compared with best supportive care alone.
Despite a large number of randomized trials, there is no consensus as to the best agent or regimen. In general, combination chemotherapy regimens provide higher response rates than do single agent, however, this translates into only a modest improvement in outcome with a trade off in increased treatment toxicities. The key challenge in managing patients with advanced gastric cancer is to identify the appropriate drugs for patients who might benefit for palliative chemotherapy.
Gastric cancer is a heterogeneous disease with differing chemosensitivities to anti-cancer drugs. Current selection of standard therapy is often empirical. Gene expression profiling has been shown to have the capability to dissect this heterogeneity allowing for sub-classification and risk-stratification of cancers according to their biological features and clinical outcome. Utilising gene expression data coupled with in-vitro, in-vivo or clinical response data is a promising strategy that may enable clinicians to match the right drug to the right patient.
The purpose of the study are:
- Assess the feasibility of genomic-guided therapy
- Evaluated treatment response of standard-of-care chemotherapy in an enriched patient groups defined as 'responder' based on genomic-guided therapy
- Conditions
- Recurrent Gastric Cancer
- Being tested
- TS-1 with cisplatin, TS-1 with oxaliplatin
- Keywords
- advanced, metastatic
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-1 with cisplatinDrug
Also called TS-1 with cis-diamminedichloroplatinum
TS-1 with oxaliplatinDrug
Also called TS-1 with 3rd-generation platinum analog
| Study group | Role | What they receive |
|---|---|---|
| TS-1 with cisplatin | Experimental | Chemotherapy injection (60mg/m2 cisplatin) will be given on day 1.
14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days. Receives: Drug: TS-1 with cisplatin |
| TS-1 with oxaliplatin | Experimental | Chemotherapy injection (100mg/m2 oxaliplatin) will be given on day 1.
14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days. Receives: Drug: TS-1 with oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (RR)
To determine the response rate of cisplatin/TS-1 and oxaliplatin/TS-1 combination in predicted 'responders'
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 posted9 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent Gastric CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Centre, Singapore, Yonsei University
- Responsible party
- Sponsor
- Investigators
- Wei Peng Yong, MRCP, MB ChB, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100801
- Sponsor's protocol ID
- GA01/01/10
- Other IDs
- 2010/00064
- Acronym
- 3G
- Status last verified
- Jun 2016
- First submitted
- 7 Apr 2010
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Arai W, Hosoya Y, Hyodo M, Yokoyama T, Hirashima Y, Yasuda Y, Nagai H, Shirasaka T. Alternate-day oral therapy with TS-1 for advanced gastric cancer. Int J Clin Oncol. 2004 Jun;9(3):143-8. doi: 10.1007/s10147-004-0381-9.
PubMed 15221596Koizumi W. Chemotherapy for advanced gastric cancer: review of global and Japanese status. Gastrointest Cancer Res. 2007 Sep;1(5):197-203.
PubMed 19262709
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT01100801
- Acronym / sponsor ID
- 3G / GA01/01/10
- Conditions
- Recurrent Gastric Cancer
- Keywords
- advanced, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Cancer Centre, Singapore, Yonsei University
- Study start
- Jul 2010
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Apr 2010 (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 is an open, non-randomized, multicenter Phase II study evaluating cisplatin plus TS-1 or oxaliplatin plus TS-1 as first-line therapy in predicted 'responder' to platinum and fluoropyrimidine.
This study is planned in 3 centers in Singapore and Korea. A total of 30 subjects will be enrolled into each treatment arms. Each centers will recruit 15-25 subjects predicted to be 'responder' to platinum and fluoropyrimidine. The study will consist of a prescreening period, a screening period and a treatment period. A fresh tumour biopsy sample will be obtained during the prescreening period for gene expression profiling.
As this is a genomics guided trial, obtaining tissue biopsies is vital to the conduct of the trial.
Patients will have the primary in situ (requirement for entry into trial), endoscopic biopsy performed prior to 1st cycle.
Detailed description
Gastric cancer is the world's second leading cause of cancer death. For patients with unresectable disease or recurrent disease after surgery, the main therapeutic option is chemotherapy. Chemotherapy can improve survival and quality of life in patients with advanced disease when compared with best supportive care alone.
Despite a large number of randomized trials, there is no consensus as to the best agent or regimen. In general, combination chemotherapy regimens provide higher response rates than do single agent, however, this translates into only a modest improvement in outcome with a trade off in increased treatment toxicities. The key challenge in managing patients with advanced gastric cancer is to identify the appropriate drugs for patients who might benefit for palliative chemotherapy.
Gastric cancer is a heterogeneous disease with differing chemosensitivities to anti-cancer drugs. Current selection of standard therapy is often empirical. Gene expression profiling has been shown to have the capability to dissect this heterogeneity allowing for sub-classification and risk-stratification of cancers according to their biological features and clinical outcome. Utilising gene expression data coupled with in-vitro, in-vivo or clinical response data is a promising strategy that may enable clinicians to match the right drug to the right patient.
The purpose of the study are:
- Assess the feasibility of genomic-guided therapy
- Evaluated treatment response of standard-of-care chemotherapy in an enriched patient groups defined as 'responder' based on genomic-guided therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TS-1 with cisplatin | Experimental | Drug: TS-1 with cisplatinChemotherapy injection (60mg/m2 cisplatin) will be given on day 1. 14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days. |
| TS-1 with oxaliplatin | Experimental | Drug: TS-1 with oxaliplatinChemotherapy injection (100mg/m2 oxaliplatin) will be given on day 1. 14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically documented locally advanced, metastatic or recurrent gastric cancer for which convention therapy of a platinum/fluoropyrimidine combination is indicated
- Predicted 'responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in-vitro sensitivity array
- At least one measurable defined by RECIST
- Age >=21 years old
- Performance status (ECOG) 0-2
Key exclusion criteria (11 listed)
- Prior chemotherapy for gastric cancer except neoadjuvant or adjuvant systemic therapy if terminated at least 6 months before the start of treatment in this study
- Prior radiotherapy was administered to target lesions selected for this study
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- Presence of symptomatic or progressing CNS metastasis
- Serious illness or medical conditions:
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 |
|---|---|---|
| TS-1 with cisplatinAlso: TS-1 with cis-diamminedichloroplatinum | Drug | TS-1 with cisplatin |
| TS-1 with oxaliplatinAlso: TS-1 with 3rd-generation platinum analog | Drug | TS-1 with oxaliplatin |
Primary outcome
Response Rate (RR)
Time frame: 1 year
To determine the response rate of cisplatin/TS-1 and oxaliplatin/TS-1 combination in predicted 'responders'
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Background: PubMed 15221596Arai W, Hosoya Y, Hyodo M, Yokoyama T, Hirashima Y, Yasuda Y, Nagai H, Shirasaka T. Alternate-day oral therapy with TS-1 for advanced gastric cancer. Int J Clin Oncol. 2004 Jun;9(3):143-8. doi: 10.1007/s10147-004-0381-9.
- Background: PubMed 19262709Koizumi W. Chemotherapy for advanced gastric cancer: review of global and Japanese status. Gastrointest Cancer Res. 2007 Sep;1(5):197-203.
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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.
Wei Peng Yong, MRCP, MB ChB principal investigator
National University Hospital, Singapore
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 TS-1 with cisplatin and TS-1 with oxaliplatin in people with Recurrent Gastric Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 11 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 22 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 Singapore. 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 Wei Peng Yong, MRCP,MB ChB (65 6772 4670, Wei_Peng_Yong@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (RR) (time frame: 1 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 NCT01100801, which also lists 2 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 22 Jun 2016.