Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy

Chemotherapy Effect Clinical Trial

Official title:

Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy: A Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435767
• Other study ID #: CICAMS
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it.

log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.

In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenoma
• Ampullary Adenoma
• Chemotherapy Effect

Intervention

Drug:
• Adjuvant chemotherapy
In the Cancer Hospital, postoperative chemotherapy regimens and doses were planned by oncologists, with adjustments made based on drug toxicities or tumor responses.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The role of adjuvant chemotherapy(ACT)	The association between ACT and Overall Survival (OS) of patients	1 year
Secondary	The role of adjuvant chemotherapy(ACT)	The association between ACT and Cancer-specific Survival (CSS) of patients	1 year
Secondary	The role of adjuvant chemotherapy(ACT)	The association between ACT and Recurrence-free Survival (RFS) of patients	1 year