Gastric CancerPhase 1/2NCT00209729
Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer.
A Phase 1/2 study testing Taxotere and TS-1 in people with Gastric Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site in Japan.
Trial summary
To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the antitumor effect and survival period by performing a phase I/II study of this combination in Elderly patients with inoperable or with postoperative gastric cancer. Read more about this study
- Who is it for?
- Ages 76 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Taxotere and TS-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2005to Mar 2010
- Phase
- Phase 1/2
- 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 76 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histological diagnosis of gastric adenocarcinoma.
- Measurable or assessable lesions(Except for Phase I).
- Age: 76 ~ 80 years.
- Performance Status (ECOG): 0 ~ 2.
- No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
- No history of treatment with Docetaxel or S-1.
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- No history of radiotherapy to the abdomen.
- Oral intake of S-1 is possible.
- Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5 times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
- Predicted survival for >3 months.
- Able to give written informed consent.
Who cannot join
- Severe pleural effusion or ascites.
- Metastasis to the central nervous system (CNS).
- Active gastrointestinal bleeding.
- Active infection.
- Diarrhea (watery stools).
- Uncontrolled ischemic heart disease.
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- Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- Active multiple cancer.
- Severe mental disorder.
- Pregnancy, possible pregnancy, or breast-feeding.
- Flucytosine treatment.
- Judged to be ineligible for this protocol by the attending physician.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Sapporo, Hokkaido, 060-8638
About this study
Official title: Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer
To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the antitumor effect and survival period by performing a phase I/II study of this combination in Elderly patients with inoperable or with postoperative gastric cancer.
Read the detailed description
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on Elderly patients with histological stage IV gastric cancer given Docetaxel plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
- Conditions
- Gastric Cancer
- Being tested
- Taxotere, TS-1
- Keywords
- Docetaxel, S-1, Elderly Patients, 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.
TaxotereDrug
Also called Docetaxel
X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.
TS-1Drug
Also called S-1
Day 1-14, P.O. everyday
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Docetaxel plus S-1 Receives: Drug: Taxotere; Drug: TS-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.
Measured: 1-year
Secondary outcomes (2)
Determine the clinical response rate of patients in Phase I setting.
Measured: 1-year
Determine the OS(Overall Survival) and DFS(Disease Free Survival).
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2009 (estimated)
- Study completionMar 2010 (estimated)
Why it stopped: Registration is less
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hokkaido Gastrointestinal Cancer Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Hokkaido University Hospital
- Investigators
- Masahiro Asaka, MD, PhD, Study chair, Hokkaido Gastrointestinal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209729
- Sponsor's protocol ID
- HGCSG0502
- Other IDs
- DS-Elderly
- Status last verified
- May 2010
- First submitted
- 13 Sep 2005
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00209729
- Acronym / sponsor ID
- HGCSG0502
- Conditions
- Gastric Cancer
- Keywords
- Docetaxel, S-1, Elderly Patients, Gastric cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Registration is less
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hokkaido Gastrointestinal Cancer Study GroupUniversity, hospital or other
- Collaborators
- Hokkaido University Hospital
- Study start
- Apr 2005
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 21 Sep 2005 (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 assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the antitumor effect and survival period by performing a phase I/II study of this combination in Elderly patients with inoperable or with postoperative gastric cancer.
Detailed description
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on Elderly patients with histological stage IV gastric cancer given Docetaxel plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Taxotere, Drug: TS-1Docetaxel plus S-1 |
Who may qualify
- Ages
- 76 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Histological diagnosis of gastric adenocarcinoma.
- Measurable or assessable lesions(Except for Phase I).
- Age: 76 ~ 80 years.
- Performance Status (ECOG): 0 ~ 2.
- No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
Key exclusion criteria (12 listed)
- Severe pleural effusion or ascites.
- Metastasis to the central nervous system (CNS).
- Active gastrointestinal bleeding.
- Active infection.
- Diarrhea (watery stools).
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 |
|---|---|---|
| TaxotereAlso: DocetaxelX mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle. | Drug | 1 |
| TS-1Also: S-1Day 1-14, P.O. everyday | Drug | 1 |
Primary outcome
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.
Time frame: 1-year
2 secondary outcomes
Determine the clinical response rate of patients in Phase I setting.
Time frame: 1-year
Determine the OS(Overall Survival) and DFS(Disease Free Survival).
Time frame: 2-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
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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.
Masahiro Asaka, MD, PhD study chair
Hokkaido Gastrointestinal Cancer Study Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Taxotere and TS-1 in people with Gastric Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site 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 12 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: paused, as of the sponsor's last update on 26 May 2010. 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting. (time frame: 1-year). 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 26 May 2010.