Gastric CancerPhase 2NCT00088816
S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
A Phase 2 study testing cisplatin, tegafur-gimeracil-oteracil potassium and adjuvant therapy in people with Gastric Cancer, run by Kyoto University at 7 sites in Japan.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- cisplatin, tegafur-gimeracil-oteracil potassium and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 7 sitesJapan
- Study dates
- Apr 2003to Mar 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed gastric adenocarcinoma
- Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:
- T4, N2
- T4, N3
- P1, CY1
- CT scan and laparoscopic staging required
PATIENT CHARACTERISTICS:
Age
- 20 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 4,000/mm^3 AND < 12,000/mm^3
- Granulocyte count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
Renal
- Creatinine clearance ≥ 50 mL/min
Pulmonary
- PaO_2 ≥ 70 mm Hg on room air
Other
- Able to swallow oral medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for gastric cancer
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for gastric cancer
Surgery
- No prior surgery for gastric cancer
Other
- No other prior therapy for gastric cancer
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Shimane Prefectural Central Hospital
Izumo-shi, Shimane, 693-0068
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
National Hospital Organization - Kyoto Medical Center
Kyoto, Kyoto, 612-0861
Kyoto-Katsura Hospital
Kyoto, Kyoto, 615-8256
Kitano Hospital
Osaka, Osaka, 530-8480
Kansai Denryoku Hospital
Osaka, Osaka, 553-0003
Yamato Municipal Hospital
Yamato City Kanagawa, 242-8602
About this study
Official title: Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma.
- Determine the overall survival of patients treated with this regimen.
Secondary
- Determine the time to progression and types of initial recurrence in patients treated with this regimen.
- Determine tumor response in patients treated with this regimen.
- Determine mortality and morbidity related to treatment in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Conditions
- Gastric Cancer
- Being tested
- cisplatin, tegafur-gimeracil-oteracil potassium, adjuvant therapy, conventional surgery, neoadjuvant therapy
- Keywords
- stage IV gastric cancer, adenocarcinoma of the stomach
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
tegafur-gimeracil-oteracil potassiumDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (8)
Time to progression
Tumor response
Death related to treatment
Histological response
Postoperative complications
Surgical/pathological curative resection
Types of initial recurrence
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startApr 2003
- Primary completionMar 2008 (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 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Investigators
- Seiji Satoh, Study chair, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088816
- Sponsor's protocol ID
- CDR0000368443
- Other IDs
- KYUH-UHA-GC03-01
- Status last verified
- Mar 2008
- First submitted
- 4 Aug 2004
- Last updated
- 17 Sep 2013
- Results posted
- No
Publications
Satoh S, Okabe H, Teramukai S, Hasegawa S, Ozaki N, Ueda S, Tsuji A, Sakabayashi S, Fukushima M, Sakai Y. Phase II trial of combined treatment consisting of preoperative S-1 plus cisplatin followed by gastrectomy and postoperative S-1 for stage IV gastric cancer. Gastric Cancer. 2012 Jan;15(1):61-9. doi: 10.1007/s10120-011-0066-9. Epub 2011 Jun 11.
PubMed 21667134
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00088816
- Acronym / sponsor ID
- CDR0000368443
- Conditions
- Gastric Cancer
- Keywords
- stage IV gastric cancer, adenocarcinoma of the stomach
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Mar 2008 (estimated)
- First posted
- 5 Aug 2004 (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.
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma.
- Determine the overall survival of patients treated with this regimen.
Secondary
- Determine the time to progression and types of initial recurrence in patients treated with this regimen.
- Determine tumor response in patients treated with this regimen.
- Determine mortality and morbidity related to treatment in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cisplatin | Drug | – |
| tegafur-gimeracil-oteracil potassium | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Overall survival
8 secondary outcomes
Time to progression
Tumor response
Death related to treatment
Histological response
Postoperative complications
Surgical/pathological curative resection
Types of initial recurrence
Adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Results publication: PubMed 21667134Satoh S, Okabe H, Teramukai S, Hasegawa S, Ozaki N, Ueda S, Tsuji A, Sakabayashi S, Fukushima M, Sakai Y. Phase II trial of combined treatment consisting of preoperative S-1 plus cisplatin followed by gastrectomy and postoperative S-1 for stage IV gastric cancer. Gastric Cancer. 2012 Jan;15(1):61-9. doi: 10.1007/s10120-011-0066-9. Epub 2011 Jun 11.
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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.
Seiji Satoh study chair
Kyoto University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, tegafur-gimeracil-oteracil potassium and adjuvant therapy in people with Gastric Cancer, run by Kyoto University at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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?
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?
Overall survival. 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 NCT00088816, 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 17 Sep 2013.