Advanced Gastric CancerPhase 3NCT00821990
Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer
A Phase 3 study testing Chemotherapy in people with Advanced Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Because well-designed, randomized, controlled clinical trials are lacking in patients with advanced gastric cancer (AGC), and because randomly allocating patients to treatments that do not accord with their preferences may influence trial validity, the investigators employed a patient preference randomized trial… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Jun 2011
- Phase
- Phase 3
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged 75 year or younger
- advanced gastric cancer
- ECOG performance status 0 or 1
- previous failure after chemotherapy with fluoropyrimidine and platinum
- adequate major organ functions
Who cannot join
- severe concurrent illness and/or active infection
- previously treated with taxanes and irinotecan
- active CNS metastases
- pregnant or lactating women
- who have not recovered from prior treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Patient Preference Randomized Phase III Clinical Trial of Second-line Chemotherapy (SLC) in Advanced Gastric Cancer (AGC) Patients Pretreated With Both Fluoropyrimidines and Platinum
Because well-designed, randomized, controlled clinical trials are lacking in patients with advanced gastric cancer (AGC), and because randomly allocating patients to treatments that do not accord with their preferences may influence trial validity, the investigators employed a patient preference randomized trial design to compare the efficacy of second-line chemotherapy and best supportive care.
Read the detailed description
Fluoropyrimidine and/or platinum-based chemotherapy is now regarded as a standard first-line treatment in AGC patients because it has shown superiority in terms of response rate and time to disease progression compared with 5-FU monotherapy and other combinations in phase III trials. Despite the lack of evidence for benefit associated with administering salvage chemotherapy, it is a common practice to offer further chemotherapy for AGC patients after first-line failure. For patients who failed after fluoropyrimidine and platinum, taxanes (paclitaxel or docetaxel) and irinotecan have been evaluated extensively in the second-line setting.
Currently, there is no evidence that SLC in patients with AGC will result in substantial prolongation of survival and there is potential for toxicity from the treatment.
- Conditions
- Advanced Gastric Cancer
- Being tested
- Chemotherapy, Best supportive care
- Keywords
- Failed after previous chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
The administration of chemotherapy regimen (docetaxel or irinotecan) will be determined at the discretion of investigator, and depends on the patient's previous chemotherapy.
Best supportive careOther
It includes nutritional support, analgesics, antibiotics, antiemetics, transfusions, or any other symptomatic therapy (with the exception of cytotoxic chemotherapy) and/or assistance of a psychological support. Localized radiotherapy to alleviate symptoms such as pain is allowed provided that the total dose delivered is in a palliative range.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Active comparator | Eligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care). Receives: Drug: Chemotherapy; Other: Best supportive care |
| Supportive care | Active comparator | Eligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care). Receives: Other: Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 1 year after last patient entered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionJun 2011
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 Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Se Hoon Park, MD, Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821990
- Sponsor's protocol ID
- 2008-08-055
- Status last verified
- Jan 2012
- First submitted
- 29 Dec 2008
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006 Jun 20;24(18):2903-9. doi: 10.1200/JCO.2005.05.0245.
PubMed 16782930Wilson D, Hiller L, Geh JI. Review of second-line chemotherapy for advanced gastric adenocarcinoma. Clin Oncol (R Coll Radiol). 2005 Apr;17(2):81-90. doi: 10.1016/j.clon.2004.10.006.
PubMed 15830569
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Preference Randomized Phase III Clinical Trial of Second-line Chemotherapy (SLC) in Advanced Gastric Cancer (AGC) Patients Pretreated With Both Fluoropyrimidines and Platinum
- ClinicalTrials.gov ID
- NCT00821990
- Acronym / sponsor ID
- 2008-08-055
- Conditions
- Advanced Gastric Cancer
- Keywords
- Failed after previous chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Jan 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.
Because well-designed, randomized, controlled clinical trials are lacking in patients with advanced gastric cancer (AGC), and because randomly allocating patients to treatments that do not accord with their preferences may influence trial validity, the investigators employed a patient preference randomized trial design to compare the efficacy of second-line chemotherapy and best supportive care.
Detailed description
Fluoropyrimidine and/or platinum-based chemotherapy is now regarded as a standard first-line treatment in AGC patients because it has shown superiority in terms of response rate and time to disease progression compared with 5-FU monotherapy and other combinations in phase III trials. Despite the lack of evidence for benefit associated with administering salvage chemotherapy, it is a common practice to offer further chemotherapy for AGC patients after first-line failure. For patients who failed after fluoropyrimidine and platinum, taxanes (paclitaxel or docetaxel) and irinotecan have been evaluated extensively in the second-line setting.
Currently, there is no evidence that SLC in patients with AGC will result in substantial prolongation of survival and there is potential for toxicity from the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Active comparator | Drug: Chemotherapy, Other: Best supportive careEligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care). |
| Supportive care | Active comparator | Other: Best supportive careEligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care). |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- aged 75 year or younger
- advanced gastric cancer
- ECOG performance status 0 or 1
- previous failure after chemotherapy with fluoropyrimidine and platinum
- adequate major organ functions
Key exclusion criteria (5 listed)
- severe concurrent illness and/or active infection
- previously treated with taxanes and irinotecan
- active CNS metastases
- pregnant or lactating women
- who have not recovered from prior treatments
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 |
|---|---|---|
| ChemotherapyThe administration of chemotherapy regimen (docetaxel or irinotecan) will be determined at the discretion of investigator, and depends on the patient's previous chemotherapy. | Drug | Chemotherapy |
| Best supportive careIt includes nutritional support, analgesics, antibiotics, antiemetics, transfusions, or any other symptomatic therapy (with the exception of cytotoxic chemotherapy) and/or assistance of a psychological support. Localized radiotherapy to alleviate symptoms such as pain is allowed provided that the total dose delivered is in a palliative range. | Other | Chemotherapy, Supportive care |
Primary outcome
Survival
Time frame: 1 year after last patient entered
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 20 Jan 2012.
- Background: PubMed 16782930Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006 Jun 20;24(18):2903-9. doi: 10.1200/JCO.2005.05.0245.
- Background: PubMed 15830569Wilson D, Hiller L, Geh JI. Review of second-line chemotherapy for advanced gastric adenocarcinoma. Clin Oncol (R Coll Radiol). 2005 Apr;17(2):81-90. doi: 10.1016/j.clon.2004.10.006.
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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.
Se Hoon Park, MD principal investigator
Samsung Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chemotherapy in people with Advanced Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 5 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 20 Jan 2012. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Survival (time frame: 1 year after last patient entered). 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 NCT00821990, 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 20 Jan 2012.