Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study

• Conditions: Adjuvant Chemoradiotherapy; Surgery; Resectable Pancreatic Cancer
• Interventions: Other: Follow-up only; Drug: Adjuvant chemotherapy; Radiation: Adjuvant chemoradiotherapy + Adjuvant chemotherapy; Radiation: Adjuvant chemoradiotherapy

• Registration Number: NCT04737551
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

This is a prospective observation cohort study to evaluate efficacy of different types of adjuvant therapy strategies, including chemoradiotherapy, chemotherapy alone, or no adjuvant treatment, for pancreatic ductal adenocarcinoma patients who received surgical resection of primary cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-01-25
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-01
• Last Update Submitted: 2021-02-01
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age between 18 to 90 years.
2. Received surgical resection of primary tumor.
3. Histological diagnosis of pancreatic ductal adenocarcinoma.
4. Signed informed consent.

Exclusion Criteria

1.Active concomitant malignancy (Malignancy other than pancreatic cancer).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No adjuvant treatment	Follow-up only	Pancreatic cancer patients who received surgery without subsequent adjuvant treatment.
Adjuvant chemotherapy	Adjuvant chemotherapy	Pancreatic cancer patients who received surgery and only adjuvant chemotherapy.
Adjuvant chemoradiotherapy + adjuvant chemotherapy	Adjuvant chemoradiotherapy + Adjuvant chemotherapy	Pancreatic cancer patients who received surgery and both adjuvant chemoradiotherapy and chemotherapy.
Adjuvant chemoradiotherapy	Adjuvant chemoradiotherapy	Pancreatic cancer patients who received surgery and only adjuvant chemoradiotherapy.

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to 60 months	Overall survival (OS) was defined as the time interval from the date of surgery to the date of death due to any cause or the date a patient was last known to be alive. Estimated by using the Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	Up to 48 months	Disease free survival (DFS) was defined as the time interval from the date of surgery to the date of disease recurrence or death or the date of a participant was last known to be alive without disease recurrence. Response was evaluated according to revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China