Preoperative chemotherapy for locally advanced gastric cancer
Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer
This study is testing if a specific chemotherapy treatment can help patients with locally advanced stomach cancer before they have surgery to remove the tumor.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT03825861 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed gastric adenocarcinoma that is amenable to surgical resection and meets specific locally advanced disease criteria.
Not a fit: Patients with unresectable gastric cancer, other active neoplasms, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and survival rates for patients with locally advanced gastric cancer.
How similar studies have performed: Other studies using the FOLFIRINOX regimen have shown promising results in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.