Comparing upfront surgery to chemotherapy followed by surgery for advanced gastric cancer
Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer (SNAC Study): An Observational Retrospective Multicenter Study With Matched Treatment Comparison
San Luigi Gonzaga Hospital · NCT06472063
This study is trying to see if having surgery right away is just as good as getting chemotherapy first before surgery for people with advanced stomach cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 684 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | San Luigi Gonzaga Hospital (other) |
| Locations | 1 site (Orbassano, Piedmont) |
| Trial ID | NCT06472063 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the non-inferiority of upfront surgery with optimal D2 lymphadenectomy compared to neoadjuvant chemotherapy followed by surgery in patients with resectable advanced gastric cancer. It will include patients with locally advanced adenocarcinoma of the stomach who underwent either treatment approach between January 2012 and December 2019. The study will analyze outcomes based on a matched comparison of the two therapeutic strategies, focusing on survival and efficacy. Data will be collected retrospectively from multiple centers across the nation.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with locally advanced, histologically proven gastric adenocarcinoma that is resectable and without distant metastases.
Not a fit: Patients with distant metastases, infiltration of adjacent structures, or those with non-resectable gastric cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment approach for advanced gastric cancer, potentially improving patient outcomes.
How similar studies have performed: Previous studies have explored similar treatment comparisons, but this specific approach focusing on upfront surgery versus neoadjuvant chemotherapy is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 3.1.1. Locally advanced (T\>2 any N or N+ any T) histologically proven adenocarcinoma of the stomach without distant metastases (M0) and without infiltration of adjacent structures and organs. 3.1.2. D2 lymphadenectomy (based on Japanese gastric cancer guideline) 3.1.3. Age \> 18 years 3.1.4. surgical resectability 3.1.5. follow-up time of at least 36 months. Exclusion Criteria: 3.2.1. distant metastases (cM+) or infiltration of adjacent structures or organs (cT4b) and all primarily not resectable stages 3.2.2. Other types of lymphadenectomy lower than D2 3.2.3. Siewert type I and II Cardia cancers 3.2.2. Relapsed gastric cancers 3.2.3. malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma) \-
Where this trial is running
Orbassano, Piedmont
- San Luigi University Hospital — Orbassano, Piedmont, Italy (RECRUITING)
Study contacts
- Study coordinator: Rossella Reddavid, MD
- Email: rossella.reddavid@unito.it
- Phone: +393479848651
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.
Conditions: Gastric Cancer, upfront surgery, perioperative treatment, D2 lymphadenectomy