Identifying ampullary cancer patients who may benefit from chemotherapy
Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy: A Retrospective Cohort Study
This study is trying to see if chemotherapy after surgery can help people with ampullary cancer live longer, by looking at certain factors to find out who might benefit the most.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06435767 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of adjuvant chemotherapy in improving long-term survival for patients with ampullary adenocarcinoma following curative resection. It focuses on the log odds of positive lymph nodes (LODDS) as a quantitative measure to identify patients who may benefit from chemotherapy. The study aims to clarify the effectiveness of postoperative chemotherapy and compare LODDS with traditional T and N classifications in predicting patient outcomes. By analyzing these factors, the study seeks to provide insights into personalized treatment approaches for this rare cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with pathologically confirmed ampullary adenocarcinoma who have undergone curative-intent surgical resection and do not have distant metastasis.
Not a fit: Patients who have received neoadjuvant therapy or radiotherapy, or those with incomplete clinical or follow-up information, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which ampullary adenocarcinoma patients are most likely to benefit from adjuvant chemotherapy, potentially improving survival rates.
How similar studies have performed: While the approach of using LODDS to identify chemotherapy benefits is relatively novel, similar studies in other cancers have shown promising results in personalizing treatment based on nodal involvement.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pathologically confirmed AA patients without distant metastasis treated with curative-intent resection Exclusion Criteria: patients who received neoadjuvant therapy or radiotherapy, as well as those with missing clinical pathological or follow-up information
Where this trial is running
Beijing
- Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)
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.