ElderlyPhase 2NCT00961077
Attenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
A Phase 2 study testing S-1 (TS-1) and Oxaliplatin (Oxalitin) in people with Elderly and S-1, run by Soonchunhyang University Hospital.
Trial summary
Stomach cancer is the most common malignant disease and the second most common cause of cancer-related deaths in the Korea. The elderly are primarily affected by the disease with most gastric cancer-related deaths occuring in patients aged 65 years or older. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Elderly, S-1, Oxaliplatin
- What is being tested?
- S-1 (TS-1) and Oxaliplatin (Oxalitin)
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Aug 2012
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age : more than 70 to 80 and ECOG PS 0-2
- Age : more than 65 to less than 70 and ECOG PS 2
- Histological or pathologically confirmed adenocarinoma
- Relapsed or metastatic adenocarcinoma of stomach
- No previous chemotherapy except adjuvant chemotherapy completed at least 12 months before enrollment
- At least more than one measurable lesion on RECIST criteria
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- No radiation history for the target lesion
- An estimated life expectancy of more than 3 months
- Ability for adequate oral intake
- Adequate BM function: defined as WBC≥4000/μL, ANC ≥1500/μL, PLT≥100,000/μL.
- Adequate renal function: defined as Creatinine <1.5mg/dL.
- Adequate hepatic function: defined as total bilirubin < 2.0mg/dL, SGOT/SGPT < normal x 3.
- Written informed consent
Who cannot join
- Symptomatic brain metastasis or meningeal metastasis.
- Double primary cancer
- Medical history of other cancer within 5 years
- G-I bleeding or intestinal obstruction (other condition that can't have the oral intake)
- Hypersensitivity to the 5-FU or oxaliplatin
- Active infectious disease that need to treat systemically
- Serious medical or psychologic condition: newly developed AMI ( within 6Ms)…
About this study
Official title: A Prospective Phase II Study of Attenuated S-1 and Oxaliplatin(Attenuated SOX) as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
Stomach cancer is the most common malignant disease and the second most common cause of cancer-related deaths in the Korea. The elderly are primarily affected by the disease with most gastric cancer-related deaths occuring in patients aged 65 years or older. Systemic chemotherapy improves the quantity and quality of life in patients with gastric cancer when compared with best supportive care. However, elderly cancer patients often present with concomitant co-morbidities and age-associated physiologic problems that make the selection of optimal treatment difficult. There is also uncertainty about the use of systemic palliative chemotherapy in elderly patients because of under representation of this age group in clinical trials. Therefore, this phase II trial was planned to investigate efficacy and toxicities of combination chemotherapy with attenuated dose of S-1 and oxaliplatin (attenuated SOX)in patients with elderly AGC
Read the detailed description
Treatment scheme
- S-1 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours
Each cycle is repeated every 3 weeks
Response evaluation will be performed every 2 cycles
Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity.
- Conditions
- Elderly, S-1, Oxaliplatin, First-Line, Gastric Cancer
- Being tested
- S-1 (TS-1) and Oxaliplatin (Oxalitin)
- Keywords
- elderly, S-1, Oxaliplatin, relapsed or metastatic gastric cancer
- Medical subject headings
- Stomach Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 (TS-1) and Oxaliplatin (Oxalitin)Drug
S-1(TS-1) 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours
every 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC
Measured: every 2 cycles
Secondary outcomes (1)
To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen
Measured: every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sang-Cheol Lee, M.D., Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961077
- Sponsor's protocol ID
- SCH-HO-GC-01
- Status last verified
- Aug 2009
- First submitted
- 17 Aug 2009
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Attenuated S-1 and Oxaliplatin(Attenuated SOX) as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00961077
- Acronym / sponsor ID
- SCH-HO-GC-01
- Conditions
- Elderly, S-1, Oxaliplatin, First-Line, Gastric Cancer
- Keywords
- elderly, S-1, Oxaliplatin, relapsed or metastatic gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 18 Aug 2009 (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.
Stomach cancer is the most common malignant disease and the second most common cause of cancer-related deaths in the Korea. The elderly are primarily affected by the disease with most gastric cancer-related deaths occuring in patients aged 65 years or older. Systemic chemotherapy improves the quantity and quality of life in patients with gastric cancer when compared with best supportive care. However, elderly cancer patients often present with concomitant co-morbidities and age-associated physiologic problems that make the selection of optimal treatment difficult. There is also uncertainty about the use of systemic palliative chemotherapy in elderly patients because of under representation of this age group in clinical trials. Therefore, this phase II trial was planned to investigate efficacy and toxicities of combination chemotherapy with attenuated dose of S-1 and oxaliplatin (attenuated SOX)in patients with elderly AGC
Detailed description
Treatment scheme
- S-1 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours
Each cycle is repeated every 3 weeks
Response evaluation will be performed every 2 cycles
Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Age : more than 70 to 80 and ECOG PS 0-2
- Age : more than 65 to less than 70 and ECOG PS 2
- Histological or pathologically confirmed adenocarinoma
- Relapsed or metastatic adenocarcinoma of stomach
- No previous chemotherapy except adjuvant chemotherapy completed at least 12 months before enrollment
Key exclusion criteria (7 listed)
- Symptomatic brain metastasis or meningeal metastasis.
- Double primary cancer
- Medical history of other cancer within 5 years
- G-I bleeding or intestinal obstruction (other condition that can't have the oral intake)
- Hypersensitivity to the 5-FU or oxaliplatin
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 (TS-1) and Oxaliplatin (Oxalitin)S-1(TS-1) 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours every 3 weeks | Drug | – |
Primary outcome
To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC
Time frame: every 2 cycles
1 secondary outcome
To evaluate progression free survival, overall survival, and toxicities of aSOX-regimen
Time frame: every 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
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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.
Sang-Cheol Lee, M.D. principal investigator
Soonchunhyang University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 (TS-1) and Oxaliplatin (Oxalitin) in people with Elderly and S-1, run by Soonchunhyang University Hospital.
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 13 inclusion and 7 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 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
To evaluate response rate of attenuated SOX as first-line chemotherapy in elderly patients with relapsed or metastatic AGC (time frame: every 2 cycles). 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 18 Aug 2009.