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

Primary Purpose

Treatment

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SBRT
Chemotherapy
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment focused on measuring SBRT, Locally Advanced Pancreatic Cancer, Target Delineation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhai hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

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

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

Outcomes

Primary Outcome Measures

1-year Local Control Rate (1y-LCR)
Local Control Rate

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2020
Last Updated
June 11, 2023
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04699539
Brief Title
Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment
Keywords
SBRT, Locally Advanced Pancreatic Cancer, Target Delineation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
GTV uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
GTV non-uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
SBRT: in 5-6fractions with Cyberknife.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
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 Measure Information:
Title
1-year Local Control Rate (1y-LCR)
Description
Local Control Rate
Time Frame
1-year
Secondary Outcome Measure Information:
Title
The Probability of gastrointestinal (GI) Toxicity
Description
gastrointestinal toxicity
Time Frame
1-year
Title
1-year Disease Progression-Free-Survival (DPFS)
Description
Disease Progression-Free-Survival
Time Frame
1-year
Title
Overall Survival(OS)
Description
Overall Survival
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huojun Zhang, M.D.
Phone
021-31162207
Email
chyyzhj@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lingong Jiang, M.D.
Phone
021-31162214
Email
jlarry1988@163.com
Facility Information:
Facility Name
Changhai hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huojun Zhang, M.D.
Phone
+8613311732399
Email
chyyzhj@163.com
First Name & Middle Initial & Last Name & Degree
Huojun Zhang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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