Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— FOLFIRINOX  

Official title:

Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825861
• Other study ID #: 933/16
• Status: Recruiting
• Phase: Phase 2
• Start date: February 23, 2017
• Est. completion date: December 30, 2026

Study information

• Verified date: November 2020
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Tiago B. Castria, MD PhD
• Phone: +551138934531
• Email: tiagobiachi[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• FOLFIRINOX
Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.

Locations

Country	Name	City	State
Brazil	Instituto do Câncer do Estado de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response (pCR)	To evaluate the Pathologic Complete Response (pCR).	4-8 weeks after neoadjuvant chemotherapy complete
Secondary	Disease-free survival (DFS)	Evaluate Disease-free survival (DFS).	At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
Secondary	Overall survival (OS)	Evaluate Overall survival (OS).	At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
Secondary	R0-resection rate	Evaluate the R0 resection rate (absence of microscopic residual disease).	4-8 weeks after neoadjuvant chemotherapy complete
Secondary	Rate of Treatment Completion	Evaluate the rate of completion of treatment (chemotherapy and surgical approach).	4-8 weeks after neoadjuvant chemotherapy complete
Secondary	Rate of adverse events	Rate and description of adverse events	Through neoadjuvant chemotherapy (4 months)
Secondary	Rate of Disease Progression	Evaluate the rate of disease progression.	Through neoadjuvant chemotherapy (4 months)