Preoperative chemotherapy for locally advanced gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II single-arm study evaluates the efficacy and safety of the FOLFIRINOX chemotherapy regimen as a preoperative treatment for patients with resectable locally advanced gastric cancer. A total of 27 patients will receive the FOLFIRINOX regimen via long-term catheter every 14 days for 8 cycles, totaling 4 months of treatment. Following this, restaging tests will be conducted, and if no metastatic progression is observed, patients will undergo surgical treatment with curative intent. The study aims to determine the effectiveness and safety of this neoadjuvant approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto do Câncer do Estado de São Paulo
  São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Tiago B. Castria, MD PhD
• Email: tiagobiachi@yahoo.com.br
• Phone: +551138934531

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.