Inoperable Gastric CancerPhase 3NCT03067792
FOLFIRI Versus Docetaxel and Cisplatin as a Second-line Chemotherapy After Failure of First-line Chemotherapy in Advanced Gastric Cancer
A Phase 3 study testing 5-fluorouracil, irinotecan and leucovorin and docetaxel and cisplatin in people with Inoperable Gastric Cancer, run by Yonsei University.
Trial summary
Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy. Palliative chemotherapy had proven to be better overall survivals and quality of life in unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic regimen as a first line therapy. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Inoperable Gastric Cancer
- What is being tested?
- 5-fluorouracil, irinotecan and leucovorin and docetaxel and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to 17 Oct 2016
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 19 years old and younger than 75 years old
- Pathologically confirmed gastric cancer
- Inoperable stage at diagnosis
- experienced diseases progression in first line palliative chemotherapy
- ECOG performance status 0 or 1
- Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)
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- Adequate liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)
- Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
- Subjects who given written informed consent after being given a full description of the study
Who cannot join
- double primary cancer other than gastric cancer
- history of palliative radiation therapy
- Pregnant or on breast feeding
- Neuropathy grade > 3
- Active infection
- Symptomatic cardiopulmonary diseases
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- Active hepatitis of liver cirrhosis
- Impaired renal function
- Impaired psychologic bone marrow function
- Psychologic disorder, Severe neurologic disorder.
- hypersensitivity to chemotherapeutic agent
About this study
Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy.
Palliative chemotherapy had proven to be better overall survivals and quality of life in unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic regimen as a first line therapy. But response rate of those regimens is about 50 percent. Disappointingly most of cases are about to experience progression of disease.
Second line regimens of palliative chemotherapy are also have shown its efficacy and recommended within patients with better performance status. But There is still lack of evidences in gastric cancer patients second line chemotherapy. Several phase II trial those subjects are 2nd line palliative chemotherapy in gastric cancer had suggested that irinotecan, taxane, oxaliplatin, oral fluorouracil.Investigator assessed whether cisplatin in combination with paclitaxel would increase response rate in patient previously treated for advanced gastric cancer compared with FOFIRI regimen.
- Conditions
- Inoperable Gastric Cancer
- Being tested
- 5-fluorouracil, irinotecan and leucovorin, docetaxel and cisplatin
- Keywords
- inoperable gastric cancer, palliative chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracil, irinotecan and leucovorinDrug
In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5-fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle.
docetaxel and cisplatinDrug
In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI | Active comparator | 2nd palliative chemotherapy with FOLFIRI regimen,In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5- fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle. Response evaluation would be done after 3 cycle of chemotherapy in DP group Receives: Drug: 5-fluorouracil, irinotecan and leucovorin |
| DP | Active comparator | 2nd palliative chemotherapy with Docetaxel/cisplatin regimen, In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle. Response evaluation would be done after 2 cycle of chemotherapy in DP group Receives: Drug: docetaxel and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
CT examination would be done at 7~8 weeks after initiation of 1st cycle chemotherapeutic agent, After 2 cycle of chemotherapy in DP group and 3cyle of chemotherapy in FOFIRI group.
Measured: up to 2 year
Secondary outcomes (3)
diseases control rate
disease control, defined as the proportion of patients who had a best response of complete response, partial response, or stable
Measured: up to 2 year
Overall survival
overall survival, defined as time from randomisation to death
Measured: up to 2 year
progression free survival
progression-free survival, defined as time from randomisation to radiographic progression or death
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startDec 2014
- Primary completion17 Oct 2016
- Study completion17 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067792
- Sponsor's protocol ID
- 4-2014-0626
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOLFIRI Versus Docetaxel and Cisplatin as a Second-line Chemotherapy After Failure of First-line Chemotherapy in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT03067792
- Acronym / sponsor ID
- 4-2014-0626
- Conditions
- Inoperable Gastric Cancer
- Keywords
- inoperable gastric cancer, palliative chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 17 Oct 2016 (actual)
- Study completion
- 17 Oct 2016 (actual)
- First posted
- 1 Mar 2017 (actual)
- 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.
Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy.
Palliative chemotherapy had proven to be better overall survivals and quality of life in unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic regimen as a first line therapy. But response rate of those regimens is about 50 percent. Disappointingly most of cases are about to experience progression of disease.
Second line regimens of palliative chemotherapy are also have shown its efficacy and recommended within patients with better performance status. But There is still lack of evidences in gastric cancer patients second line chemotherapy. Several phase II trial those subjects are 2nd line palliative chemotherapy in gastric cancer had suggested that irinotecan, taxane, oxaliplatin, oral fluorouracil.Investigator assessed whether cisplatin in combination with paclitaxel would increase response rate in patient previously treated for advanced gastric cancer compared with FOFIRI regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI | Active comparator | Drug: 5-fluorouracil, irinotecan and leucovorin2nd palliative chemotherapy with FOLFIRI regimen,In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5- fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle. Response evaluation would be done after 3 cycle of chemotherapy in DP group |
| DP | Active comparator | Drug: docetaxel and cisplatin2nd palliative chemotherapy with Docetaxel/cisplatin regimen, In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle. Response evaluation would be done after 2 cycle of chemotherapy in DP group |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Older than 19 years old and younger than 75 years old
- Pathologically confirmed gastric cancer
- Inoperable stage at diagnosis
- experienced diseases progression in first line palliative chemotherapy
- ECOG performance status 0 or 1
Key exclusion criteria (11 listed)
- double primary cancer other than gastric cancer
- history of palliative radiation therapy
- Pregnant or on breast feeding
- Neuropathy grade > 3
- Active infection
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 |
|---|---|---|
| 5-fluorouracil, irinotecan and leucovorinIn FOLFIRI group, patients received irinotecan 180 mg/m2 and 5-fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle. | Drug | FOLFIRI |
| docetaxel and cisplatinIn DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle. | Drug | DP |
Primary outcome
response rate
Time frame: up to 2 year
CT examination would be done at 7~8 weeks after initiation of 1st cycle chemotherapeutic agent, After 2 cycle of chemotherapy in DP group and 3cyle of chemotherapy in FOFIRI group.
3 secondary outcomes
diseases control rate
Time frame: up to 2 year
Overall survival
Time frame: up to 2 year
progression free survival
Time frame: up to 2 year
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 1 Mar 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-fluorouracil, irinotecan and leucovorin and docetaxel and cisplatin in people with Inoperable Gastric Cancer, run by Yonsei University.
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 9 inclusion and 11 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 1 Mar 2017. 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 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?
response rate (time frame: up to 2 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 1 Mar 2017.