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

Treatment Clinical Trial

Official title:

GTV Uniform Expansion to Form PTV vs. Non-uniform Expansion to Form PTV Based on Recurrence Pattern in SBRT of Locally Advanced Pancreatic Cancer: a Phase II Clinical Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699539
• Other study ID #: Changhai Hospita
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2023
• Source: Changhai Hospital
• Contact: Huojun Zhang, M.D.
• Phone: 021-31162207
• Email: chyyzhj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Treatment

Intervention

Radiation:
• SBRT
SBRT: in 5-6fractions with Cyberknife.

Drug:
• Chemotherapy
Gemcitabine (1000mg/m2,d1, 8) + albumin-bound paclitaxel (125mg/m2,d1, 8) or single-agent oral S-1 (60-120 mg/ daily, d1-14) , repeat every 3 weeks.

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year Local Control Rate (1y-LCR)	Local Control Rate	1-year
Secondary	The Probability of gastrointestinal (GI) Toxicity	gastrointestinal toxicity	1-year
Secondary	1-year Disease Progression-Free-Survival (DPFS)	Disease Progression-Free-Survival	1-year
Secondary	Overall Survival(OS)	Overall Survival	1-year