Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer

NCT03825861 | Recruiting Phase 2

• 1 other identifier: 933/16
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; FOLFIRINOX

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR)

  To evaluate the Pathologic Complete Response (pCR).

  4-8 weeks after neoadjuvant chemotherapy complete

Secondary Outcomes (6)

• Disease-free survival (DFS)

  At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.

• Overall survival (OS)

  At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.

• R0-resection rate

  4-8 weeks after neoadjuvant chemotherapy complete

• Rate of Treatment Completion

  4-8 weeks after neoadjuvant chemotherapy complete

• Rate of adverse events

  Through neoadjuvant chemotherapy (4 months)

Study Arms (1)

FOLFIRINOX

EXPERIMENTAL

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

Drug: FOLFIRINOX

Interventions

FOLFIRINOX DRUG

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

FOLFIRINOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Tiago B. Castria, MD PhD

CONTACT

+551138934531; tiagobiachi@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 31, 2019
• Study Start: February 23, 2017
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

BR (1)