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Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer (FOLFIRINOX)

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
FOLFIRINOX
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, FOLFIRINOX

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto do Câncer do Estado de São PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFIRINOX

Arm Description

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

Outcomes

Primary Outcome Measures

Pathologic Complete Response (pCR)
To evaluate the Pathologic Complete Response (pCR).

Secondary Outcome Measures

Disease-free survival (DFS)
Evaluate Disease-free survival (DFS).
Overall survival (OS)
Evaluate Overall survival (OS).
R0-resection rate
Evaluate the R0 resection rate (absence of microscopic residual disease).
Rate of Treatment Completion
Evaluate the rate of completion of treatment (chemotherapy and surgical approach).
Rate of adverse events
Rate and description of adverse events
Rate of Disease Progression
Evaluate the rate of disease progression.

Full Information

First Posted
January 24, 2019
Last Updated
November 9, 2020
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03825861
Brief Title
Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer
Acronym
FOLFIRINOX
Official Title
Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, FOLFIRINOX

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FOLFIRINOX
Arm Type
Experimental
Arm Description
Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.
Intervention Type
Drug
Intervention Name(s)
FOLFIRINOX
Intervention Description
Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.
Primary Outcome Measure Information:
Title
Pathologic Complete Response (pCR)
Description
To evaluate the Pathologic Complete Response (pCR).
Time Frame
4-8 weeks after neoadjuvant chemotherapy complete
Secondary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
Evaluate Disease-free survival (DFS).
Time Frame
At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
Title
Overall survival (OS)
Description
Evaluate Overall survival (OS).
Time Frame
At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
Title
R0-resection rate
Description
Evaluate the R0 resection rate (absence of microscopic residual disease).
Time Frame
4-8 weeks after neoadjuvant chemotherapy complete
Title
Rate of Treatment Completion
Description
Evaluate the rate of completion of treatment (chemotherapy and surgical approach).
Time Frame
4-8 weeks after neoadjuvant chemotherapy complete
Title
Rate of adverse events
Description
Rate and description of adverse events
Time Frame
Through neoadjuvant chemotherapy (4 months)
Title
Rate of Disease Progression
Description
Evaluate the rate of disease progression.
Time Frame
Through neoadjuvant chemotherapy (4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiago B. Castria, MD PhD
Phone
+551138934531
Email
tiagobiachi@yahoo.com.br
Facility Information:
Facility Name
Instituto do Câncer do Estado de São Paulo
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiago Castria, MD PhD
Phone
+5511 3893-2000
Email
tiagobiachi@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer

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