Gastric CancerPhase 2NCT00287755
Clinical Trial of Chemosensitivity Test
A Phase 2 study testing S-1 in people with Gastric Cancer, run by Japan Clinical Cancer Research Organization at 36 sites in Japan.
Trial summary
To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 36 sitesJapan
- Study dates
- Mar 2006to Mar 2011
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- histologically proven gastric cancer
- PS (ECOG) 0 or 2
- D2 dissection, curability B or more
- surgical Stage IIIA and IIIB
- negative peritoneal cytology
- no previous radiotherapy, chemotherapy and hormone therapy
Show all 11Show fewer
- possible peroral intake at 6 POW
- no severe surgical complication
- normal bone marrow, liver and renal function
- complete chemosensitivity test
- written informed consent
Who cannot join
- multiple cancer
- contraindication for S-1
- history of drug allergy (grade 3)
- severe complication
- watery diarrhea
- pregnant
- scirrhous gastric cancer
- the other patients who was judged as inadequate for trial by doctor on duty
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Japan36 sites
Department of frontier surgery,Draduate school of medicine,Chiba University
Chiba, Chiba, 260-8670
Surugadai Nihon University Hospital
Chiyoda-ku, Tokyo, 101-8309
Kyusyu University Faculty of Medical Sciences
Fukuoka, Fukuoka, 812-8582
Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, Fukuoka, 815-8588
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Hakodate Goryoukaku Hopsital
Hakodate, Hokkaido, 040-0001
Hirakata City Hospital
Hirakata, Osaka, 573-1013
Department of surgical oncology and digestive surgery kagoshima university graduate school
Kagoshima, Kagoshima-ken, 890-8520
Kanagawa Prefectural Cancer Center
Kanagawa, Yokohama, 241-0815
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530
Kanazawa Medical University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Tobu Chiiki Hospital
Katsushika-ku, Tokyo, 125-8512
Nippon Medical School Second Hospital
Kawasaki, Kanagawa, 211-8533
St. Marianna University, School of Medicine
Kawasaki, Kanagawa, 216-8511
Cancer Institute Hospital
Koto-ku, Tokyo, 135-8550
Faculty of Medical and Pharmaceutical Sciences Kumamoto University
Kumamoto, Kumamoto, 860-8556
Gunma University Hospital
Maehashi, Gunma, 371-0034
Iwate Medical University Hospital
Morioka, Iwate, 020-8505
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8550
Niigata Prefectural Cancer Center
Niigata, Niigata, 951-8566
Osaka Kita Japan Post Hospital
Osaka, Osaka, 530-8798
Osaka City University Graduate School of Medicine
Osaka, Osaka, 545-8585
Saga Medical School Faculty of Medicine,Saga University
Saga, Saga-ken, 849-8501
Kitazato University East Hospital
Sagamihara, Kanagawa, 228-8555
Jichi Medical School Hospital
Shimono, Tochigi, 329-0498
Dokkyo University School of Medecine
Shimotsuga, Tochigi, 321-0293
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Saiseikai Suita Hospital
Suita, Osaka, 564-0013
Hyogo Prefectural Awaji Hospital
Sumoto, Hyōgo, 656-0017
Kouseiren Takaoka Hospital
Takaoka, Toyama, 933-8555
Osaka Medical College Hospital
Takatsuki, Osaka, 569-8686
Nippon Medical School Tama Nagayama Hospital
Tama, Tokyo, 206-8512
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834
Wakayama Prefectural Medical University Hospital
Wakayama, Wakayama, 641-8510
Yao Municipal Hospital
Yao, Osaka, 581-0069
Tottori University Faculty of Medicine
Yonago, Tottori, 683-8504
About this study
Official title: Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery
To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery
Read the detailed description
Patients: clinical Stage III gastric cancer patients. Informed consent will be obtained before surgery. Eligible patients: surgical Stage II, IIIA and IIIB gastric cancer patients. Chemosensitivity test: The surgical specimen will be sent Mitsubishi BCL, Co. Ltd. to be tested by CD-DST chemosensitivity test and RT-PCR for thymidylate synthetase and dihydropyrimidine dehydrogenase mRNA. The test results will be blinded for the doctors on duty.
Treatment: All the patients will be treated with S-1 at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest. The treatment will be continued until the recurrence or 1 year after operation.
Primary endpoint: 3-years disease-free survival rate Secondary endpoint: 3-years overall survival rate and side effect (CTCAE v3.0) Evaluation of chemosensitivity test: The cutoff condition will be determined based on the accumulated data of CD-DST and mRNAs.
Hypothesis: The responder detected by CD-DST and/or TS, DPD mRNA will have a favorable survival outcome comparing with resistant cases.
- Conditions
- Gastric Cancer
- Being tested
- S-1
- Keywords
- gastric cancer, S-1, chemosensitivity, adjuvant
- 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-1Drug
S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: at three years
Secondary outcomes (1)
Side effect
Measured: During administration of drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2010
- Study completionMar 2011
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japan Clinical Cancer Research Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Kitasato University
- Investigators
- Tetsuro Kubota, Processor, Principal investigator, Keio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287755
- Sponsor's protocol ID
- JACCRO GC-04
- Other IDs
- GC-04
- Status last verified
- Jun 2011
- First submitted
- 3 Feb 2006
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tanigawa N, Yamaue H, Ohyama S, Sakuramoto S, Inada T, Kodera Y, Kitagawa Y, Omura K, Terashima M, Sakata Y, Nashimoto A, Yamaguchi T, Chin K, Nomura E, Lee SW, Takeuchi M, Fujii M, Nakajima T. Exploratory phase II trial in a multicenter setting to evaluate the clinical value of a chemosensitivity test in patients with gastric cancer (JACCRO-GC 04, Kubota memorial trial). Gastric Cancer. 2016 Apr;19(2):350-360. doi: 10.1007/s10120-015-0506-z. Epub 2015 Sep 18.
PubMed 26385385
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery
- ClinicalTrials.gov ID
- NCT00287755
- Acronym / sponsor ID
- JACCRO GC-04
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, S-1, chemosensitivity, adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Japan Clinical Cancer Research OrganizationUniversity, hospital or other
- Collaborators
- Kitasato University
- Study start
- Mar 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Feb 2006 (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.
To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery
Detailed description
Patients: clinical Stage III gastric cancer patients. Informed consent will be obtained before surgery. Eligible patients: surgical Stage II, IIIA and IIIB gastric cancer patients. Chemosensitivity test: The surgical specimen will be sent Mitsubishi BCL, Co. Ltd. to be tested by CD-DST chemosensitivity test and RT-PCR for thymidylate synthetase and dihydropyrimidine dehydrogenase mRNA. The test results will be blinded for the doctors on duty.
Treatment: All the patients will be treated with S-1 at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest. The treatment will be continued until the recurrence or 1 year after operation.
Primary endpoint: 3-years disease-free survival rate Secondary endpoint: 3-years overall survival rate and side effect (CTCAE v3.0) Evaluation of chemosensitivity test: The cutoff condition will be determined based on the accumulated data of CD-DST and mRNAs.
Hypothesis: The responder detected by CD-DST and/or TS, DPD mRNA will have a favorable survival outcome comparing with resistant cases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-1 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- histologically proven gastric cancer
- PS (ECOG) 0 or 2
- D2 dissection, curability B or more
- surgical Stage IIIA and IIIB
- negative peritoneal cytology
Key exclusion criteria (8 listed)
- multiple cancer
- contraindication for S-1
- history of drug allergy (grade 3)
- severe complication
- watery diarrhea
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-1S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest. | Drug | 1 |
Primary outcome
Overall survival rate
Time frame: at three years
1 secondary outcome
Side effect
Time frame: During administration of drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
- Derived from this study: PubMed 26385385Tanigawa N, Yamaue H, Ohyama S, Sakuramoto S, Inada T, Kodera Y, Kitagawa Y, Omura K, Terashima M, Sakata Y, Nashimoto A, Yamaguchi T, Chin K, Nomura E, Lee SW, Takeuchi M, Fujii M, Nakajima T. Exploratory phase II trial in a multicenter setting to evaluate the clinical value of a chemosensitivity test in patients with gastric cancer (JACCRO-GC 04, Kubota memorial trial). Gastric Cancer. 2016 Apr;19(2):350-360. doi: 10.1007/s10120-015-0506-z. Epub 2015 Sep 18.
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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.
Tetsuro Kubota, Processor principal investigator
Keio University Hospital
36 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 S-1 in people with Gastric Cancer, run by Japan Clinical Cancer Research Organization at 36 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?
The sponsor lists 11 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate (time frame: at three years). 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 NCT00287755, 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 29 Jun 2011.