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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFIRINOX | Experimental | Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFIRINOX | Drug | Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) | To evaluate the Pathologic Complete Response (pCR). | 4-8 weeks after neoadjuvant chemotherapy complete |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | Evaluate Disease-free survival (DFS). | At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen. |
| Overall survival (OS) | Evaluate Overall survival (OS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiago B. Castria, MD PhD | Contact | +551138934531 | tiagobiachi@yahoo.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Câncer do Estado de São Paulo | Recruiting | São Paulo | 01246-000 | Brazil |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000627770 | folfirinox |
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| 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). | 4-8 weeks after neoadjuvant chemotherapy complete |
| Rate of Treatment Completion | Evaluate the rate of completion of treatment (chemotherapy and surgical approach). | 4-8 weeks after neoadjuvant chemotherapy complete |
| Rate of adverse events | Rate and description of adverse events | Through neoadjuvant chemotherapy (4 months) |
| Rate of Disease Progression | Evaluate the rate of disease progression. | Through neoadjuvant chemotherapy (4 months) |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |