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

Not Applicable

Recruiting

• Conditions: Treatment
• Interventions: Radiation: SBRT; Drug: Chemotherapy

• Registration Number: NCT04699539
• Lead Sponsor: Changhai Hospital

Brief Summary

The purpose of this study is to compare the efficacy and safety of two target delineation methods in SBRT for LAPC, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Study Start: 2021-03-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Age 18-75
• Patients with a pathological diagnosis of pancreatic ductal adenocarcinoma or clinical diagnosis of pancreatic cancer after clinical multiple disciplinary team
• Patients with a clinical staging of locally advanced pancreatic cancer
• No anti-tumor treatment related to pancreas before SBRT
• Performance status is acceptable, ECOG score is 0 or 1
• Patients who voluntarily accepted the clinical trial program after informing the existing treatment plan

Exclusion Criteria

• Patients who have previously received relevant treatments in the pancreas and its surrounding areas, such as radiotherapy, chemotherapy, and local treatment
• Severe liver and kidney dysfunction
• Obstructive jaundice
• Moderate or mass ascites
• Patients with other malignant tumors, acute infection or other severe infection
• Patients with gastrointestinal ulcers and incomplete recovery, or patients with acute peptic ulcer
• Gastroscopy or imaging examination indicates that the tumor invaded the duodenum or stomach
• Patients who have participated in other clinical trials for less than three months
• Patients who are judged by researchers as unsuitable for this clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Chemotherapy	GTV uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.
Arm B	Chemotherapy	GTV non-uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.
Arm A	SBRT	GTV uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.
Arm B	SBRT	GTV non-uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.

Primary Outcome Measures

Name	Time	Method
1-year Local Control Rate (1y-LCR)	1-year	Local Control Rate

Secondary Outcome Measures

Name	Time	Method
Overall Survival(OS)	1-year	Overall Survival
The Probability of gastrointestinal (GI) Toxicity	1-year	gastrointestinal toxicity
1-year Disease Progression-Free-Survival (DPFS)	1-year	Disease Progression-Free-Survival

Trial Locations

Locations (1)

Changhai hospital; 🇨🇳 Shanghai, Shanghai, China