NCT04699539

Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer

Recurrence-pattern-based Volume Versus Conventional-volume Stereotactic Body Radiation Therapy in Locally Advanced Pancreatic Cancer: an Open-label, Randomized, Phase 2 Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of a recurrence-pattern-based-volume versus conventional-volume stereotactic body radiation therapy for locally advanced pancreatic cancer, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.

Conditions

• Treatment

Interventions

Type	Name	Description
RADIATION	SBRT	A conventional-volume stereotactic body radiation therapy: planning target volume should include gross tumor volume with a uniform 3mm margin in all directions. A recurrence-pattern-based volume stereotactic body radiation therapy: planning target volume should include gross tumor volume with a 3mm margin in the anterior and lateral directions, 10mm margin in the cranial and caudal directions that should cover the full circumstance of celiac artery and superior mesenteric artery, 15mm in the posterior direction that should cover the retroperitoneal space. The prescribed dose of PTV varies from 30-50Gy/5-6f.
DRUG	Chemotherapy	Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8) , repeat every 3 weeks for 6 cycles

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-08-16
• Completion: 2025-08-16
• First posted: 2021-01-07
• Last updated: 2025-12-10
• Results posted: 2025-12-10

Locations

1 site across 1 country: China