Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer

Who is this study for? Patients with locally advanced gastric cancer
What treatments are being studied? FOLFIRINOX
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Instituto do Câncer do Estado de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Tiago B. Castria, MD PhD
tiagobiachi@yahoo.com.br
+551138934531
Time Frame
Start Date: 2017-02-23
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 27
Treatments
Experimental: FOLFIRINOX
Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.
Related Therapeutic Areas
Sponsors
Leads: Instituto do Cancer do Estado de São Paulo

This content was sourced from clinicaltrials.gov

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