Comparing chemotherapy durations for gastric cancer patients with advanced lymph node involvement
Duration of Postoperative Adjuvant Chemotherapy (3-4 Months Versus 5-6 Months) for Gastric Cancer Patients at Pathological N3 Stage: a Retrospective Study
The First Affiliated Hospital of Zhengzhou University · NCT06194981
This study is testing whether shorter chemotherapy treatment for gastric cancer patients with advanced lymph node involvement can be just as effective and safer than longer treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06194981 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of two different durations of adjuvant chemotherapy (3-4 months vs. 5-6 months) using CapOx/SOX regimens in patients with pathological N3 gastric cancer. Given the poor prognosis associated with N3 stage gastric cancer, the study seeks to determine if a shorter chemotherapy duration can maintain effectiveness while reducing adverse effects. The research will analyze data from patients who have undergone curative surgery and received the specified chemotherapy regimens. The findings could provide insights into optimizing treatment protocols for this high-risk patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with pathological stage N3 gastric cancer who have undergone curative surgery and are starting adjuvant chemotherapy.
Not a fit: Patients who have received neoadjuvant chemotherapy or have other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that enhance patient quality of life while maintaining effective cancer control.
How similar studies have performed: Previous studies have shown success with shorter chemotherapy durations in similar contexts, suggesting potential for this approach in gastric cancer as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-80 years old 2. Pathological stage N3 GC (≥7 positive lymph nodes) after curative surgery according to the AJCC TNM staging system, 8th edition 3. Histologically confirmed R0 resection, defined as no macroscopic or microscopic residual tumor 4. Postoperative chemotherapy with CapOX or SOX doublet regimen, initiating within 6 weeks after curative gastrectomy 5. No distant metastases or gastric stump cancer 6. No other malignant tumors Exclusion Criteria: 1. Patients who had undergone neoadjuvant chemotherapy or radiotherapy 2. Patients who received capecitabine or S-1 alone or combined with biological therapy, radiation therapy, or Immunosuppressive therapy
Where this trial is running
Zhengzhou, Henan
- Department of Gastrointestinal Surgery, the First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
Study contacts
- Principal investigator: Hongyu Zhang, M.D. — The First Affiliated Hospital of Zhengzhou University
- Study coordinator: Hongyu Zhang, M.D.
- Email: hongyuzhang624@hotmail.com
- Phone: +86 18339206109
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