Gastric CancerPhase 2FOLFIRINOXNCT03825861
Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer
A Phase 2 study testing FOLFIRINOX in people with Gastric Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Phase II single-arm study designed to evaluate the efficacy and safety of preoperative chemotherapy with FOLFIRINOX regimen. The investigators will include 27 patients with resectable locally advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- FOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Feb 2017to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of gastric adenocarcinoma that is amenable to surgical resection at diagnosis, with locally advanced disease criteria for clinical evaluation (T3 tumors, T4 tumors and / or regional lymph node involvement).
- Absence of metastatic disease at a distance (computerized tomography, diagnostic laparoscopy and peritoneal lavage).
- Age 18-75 years.
- Clinical functionality by the ECOG scale between 0 and 1.
- Preserved renal function (creatinine clearance greater than 50 mL / min).
- Signature of Informed Consent Form
Who cannot join
- Active neoplasm of another primary site other than non-melanoma skin carcinoma.
- Lesions of the esophagogastric transition
- Unresectable lesions by computed tomography and / or diagnostic laparoscopy.
- Obstructive tumors (acute intestinal occlusion or subocclusion).
- Tumors with signs of significant or persistent bleeding.
- Carcinoma in situ.
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- Different histological type of adenocarcinoma.
- Gastric stump tumors.
- Previous chemotherapeutic or radiotherapy treatment.
- Current pregnancy or breastfeeding.
- Total bilirubin above 1.5mg / dL.
- Hepatic transaminases greater than 1.5 times the upper limit of normality.
- Decompensated and / or symptomatic cardiomyopathy: congestive heart failure with functional class greater than 2 by the New York Heart Association; active coronary disease; uncontrolled cardiac arrhythmia; history of acute myocardial infarction in the last 6 months.
- Psychological, familial, social or even geographical condition that potentially hinders adherence to the study protocol and the pre-established follow-up.
- Current or previous psychiatric or neurological diagnosis that is decompensated, compromises the cognition, functionality or adherence to the proposed treatment.
- Other comorbidities that are decompensated at the time of treatment.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Câncer do Estado de São Paulo
São Paulo, 01246-000
Tiago Castria, MD PhD, +5511 3893-2000, tiagobiachi@yahoo.com.br
About this study
Phase II single-arm study designed to evaluate the efficacy and safety of preoperative chemotherapy with FOLFIRINOX regimen. The investigators will include 27 patients with resectable locally advanced gastric cancer. They will receive preoperative chemotherapy with FOLFIRINOX regimen by long-term catheter every 14 days for 8 cycles accounting for a total of 4 months of systemic treatment. In the period between 4 and 8 weeks of the last cycle, restaging tests will be performed and if there is no metastatic progression of disease, the patient will undergo surgical treatment with curative intention. The objective is to evaluate whether preoperative treatment with FOLFIRINOX regimen involving continuous infusion and bolus infusion of 5-fluoruracil, irinotecan bolus and oxaliplatin bolus is effective and safe in the neoadjuvant treatment of locally advanced gastric cancer.
The planned recruitment period is 48 months (4 years). There will be a total of 4 months of preoperative chemotherapy. In case of limiting toxicity or disease progression, chemotherapy will be suspended and patients may undergo resection of the primary neoplasia at the discretion of the surgical team of the institution. Patients will be followed for 5 years after entry of the last participant in the protocol for OS and PFS evaluation. The end of the study will occur when the last participant completes their last follow-up visit, which should occur no later than 60 months after enrollment in the study.
- Conditions
- Gastric Cancer
- Being tested
- FOLFIRINOX
- Keywords
- Gastric Cancer, FOLFIRINOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRINOXDrug
Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX | Experimental | Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion. Receives: Drug: FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR)
To evaluate the Pathologic Complete Response (pCR).
Measured: 4-8 weeks after neoadjuvant chemotherapy complete
Secondary outcomes (6)
Disease-free survival (DFS)
Evaluate Disease-free survival (DFS).
Measured: At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
Overall survival (OS)
Evaluate Overall survival (OS).
Measured: At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
R0-resection rate
Evaluate the R0 resection rate (absence of microscopic residual disease).
Measured: 4-8 weeks after neoadjuvant chemotherapy complete
Rate of Treatment Completion
Evaluate the rate of completion of treatment (chemotherapy and surgical approach).
Measured: 4-8 weeks after neoadjuvant chemotherapy complete
Rate of adverse events
Rate and description of adverse events
Measured: Through neoadjuvant chemotherapy (4 months)
Rate of Disease Progression
Evaluate the rate of disease progression.
Measured: Through neoadjuvant chemotherapy (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start23 Feb 2017
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825861
- Sponsor's protocol ID
- 933/16
- Acronym
- FOLFIRINOX
- Status last verified
- Nov 2020
- First submitted
- 24 Jan 2019
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT03825861
- Acronym / sponsor ID
- FOLFIRINOX / 933/16
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, FOLFIRINOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Jan 2019 (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.
Phase II single-arm study designed to evaluate the efficacy and safety of preoperative chemotherapy with FOLFIRINOX regimen. The investigators will include 27 patients with resectable locally advanced gastric cancer. They will receive preoperative chemotherapy with FOLFIRINOX regimen by long-term catheter every 14 days for 8 cycles accounting for a total of 4 months of systemic treatment. In the period between 4 and 8 weeks of the last cycle, restaging tests will be performed and if there is no metastatic progression of disease, the patient will undergo surgical treatment with curative intention. The objective is to evaluate whether preoperative treatment with FOLFIRINOX regimen involving continuous infusion and bolus infusion of 5-fluoruracil, irinotecan bolus and oxaliplatin bolus is effective and safe in the neoadjuvant treatment of locally advanced gastric cancer.
The planned recruitment period is 48 months (4 years). There will be a total of 4 months of preoperative chemotherapy. In case of limiting toxicity or disease progression, chemotherapy will be suspended and patients may undergo resection of the primary neoplasia at the discretion of the surgical team of the institution. Patients will be followed for 5 years after entry of the last participant in the protocol for OS and PFS evaluation. The end of the study will occur when the last participant completes their last follow-up visit, which should occur no later than 60 months after enrollment in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRINOX | Experimental | Drug: FOLFIRINOXOxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological diagnosis of gastric adenocarcinoma that is amenable to surgical resection at diagnosis, with locally advanced disease criteria for clinical evaluation (T3 tumors, T4 tumors and / or regional lymph node involvement).
- Absence of metastatic disease at a distance (computerized tomography, diagnostic laparoscopy and peritoneal lavage).
- Age 18-75 years.
- Clinical functionality by the ECOG scale between 0 and 1.
- Preserved renal function (creatinine clearance greater than 50 mL / min).
Key exclusion criteria (17 listed)
- Active neoplasm of another primary site other than non-melanoma skin carcinoma.
- Lesions of the esophagogastric transition
- Unresectable lesions by computed tomography and / or diagnostic laparoscopy.
- Obstructive tumors (acute intestinal occlusion or subocclusion).
- Tumors with signs of significant or persistent bleeding.
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 |
|---|---|---|
| FOLFIRINOXOxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion. | Drug | FOLFIRINOX |
Primary outcome
Pathologic Complete Response (pCR)
Time frame: 4-8 weeks after neoadjuvant chemotherapy complete
To evaluate the Pathologic Complete Response (pCR).
6 secondary outcomes
Disease-free survival (DFS)
Time frame: At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
Overall survival (OS)
Time frame: At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
R0-resection rate
Time frame: 4-8 weeks after neoadjuvant chemotherapy complete
Rate of Treatment Completion
Time frame: 4-8 weeks after neoadjuvant chemotherapy complete
Rate of adverse events
Time frame: Through neoadjuvant chemotherapy (4 months)
Rate of Disease Progression
Time frame: Through neoadjuvant chemotherapy (4 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFIRINOX in people with Gastric Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 10 Nov 2020. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiago B. Castria, MD PhD (+551138934531, tiagobiachi@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) (time frame: 4-8 weeks after neoadjuvant chemotherapy complete). 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 10 Nov 2020.