NCT04737551

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Resectable Pancreatic Cancer
• Adjuvant Chemoradiotherapy
• Surgery

Interventions

Type	Name	Description
OTHER	Follow-up only	Only routine follow-up but no treatment
DRUG	Adjuvant chemotherapy	Chemotherapy regimens will be decided by physicians or MDT teams, basing on patients' physical status, income status, and/or desire. Toxicity was evaluated every cycle and efficacy was evaluated every two cycles. The treatment course of adjuvant chemotherapy was followed the recommendation of NCCN guideline.
RADIATION	Adjuvant chemoradiotherapy	Adjuvant CRT could be delivered before or simultaneously with adjuvant chemotherapy. Radiation used 6 MV or 15 MVX-ray beams delivering daily fractions of 180-200cGy to a total dose of 45-55Gy in 25-28 fractions using CT-based, three-dimensional conformal radiation therapy (3DRT), intensity-modulated radiation therapy (IMRT) or tomotherapy (TOMO). S-1 was administered orally at a dose of 40mg twice a day during radiation day as radiosensitizer through radiotherapy. Antiemetic medications and proton pump inhibitor were prophylactic used to reduce the occurrence of nausea and inhibit gastric acid secretion.
RADIATION	Adjuvant chemoradiotherapy + Adjuvant chemotherapy	See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-02-04
• Last updated: 2021-02-04

Locations

1 site across 1 country: China