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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04699539
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
Zhang Huo Jun, Changhai Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Treatment Radiation: SBRT Drug: Chemotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 1-year Local Control Rate (1y-LCR) [ Time Frame: 1-year ]
    Local Control Rate


Secondary Outcome Measures :
  1. The Probability of gastrointestinal (GI) Toxicity [ Time Frame: 1-year ]
    gastrointestinal toxicity

  2. 1-year Disease Progression-Free-Survival (DPFS) [ Time Frame: 1-year ]
    Disease Progression-Free-Survival

  3. Overall Survival(OS) [ Time Frame: 1-year ]
    Overall Survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699539


Contacts
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Contact: Huojun Zhang, M.D. 021-31162207 chyyzhj@163.com
Contact: Lingong Jiang, M.D. 021-31162214 jlarry1988@163.com

Locations
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China, Shanghai
Changhai hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Huojun Zhang, M.D.    +8613311732399    chyyzhj@163.com   
Principal Investigator: Huojun Zhang, M.D.         
Sponsors and Collaborators
Changhai Hospital
More Information
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Responsible Party: Zhang Huo Jun, Director, Changhai Hospital
ClinicalTrials.gov Identifier: NCT04699539    
Other Study ID Numbers: Changhai Hospita
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhang Huo Jun, Changhai Hospital:
SBRT
Locally Advanced Pancreatic Cancer
Target Delineation
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases