Different Patterns Of Target Delineation In SBRT For Locally Advanced Pancreatic Cancer

Study Overview

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

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.

N/A

Treatment

RADIATION: SBRT
DRUG: Chemotherapy

Changhai Hospita

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-11-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-06-11
First Submitted that Met QC Criteria 2021-01-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-06-13
First Posted (ACTUAL) 2021-01-07	Results First Posted N/A	Last Verified 2023-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm A GTV uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.	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.
EXPERIMENTAL: Arm B GTV non-uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.	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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm A

GTV uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.

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.

EXPERIMENTAL: Arm B

GTV non-uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.

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.

Primary Outcome Measures	Measure Description	Time Frame
1-year Local Control Rate (1y-LCR)	Local Control Rate	1-year

Secondary Outcome Measures	Measure Description	Time Frame
The Probability of gastrointestinal (GI) Toxicity	gastrointestinal toxicity	1-year
1-year Disease Progression-Free-Survival (DPFS)	Disease Progression-Free-Survival	1-year
Overall Survival(OS)	Overall Survival	1-year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Huojun Zhang, M.D.

Phone Number: 021-31162207

Email: chyyzhj@163.com

Study Contact Backup

Name: Lingong Jiang, M.D.

Phone Number: 021-31162214

Email: jlarry1988@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record