Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses

October 27, 2020 updated by: Zhang Huo Jun, Changhai Hospital

A Prospective Phase Ⅱ Clinical Study of Stereotactic Radiotherapy Combined With Chemotherapy With Different Biological Effective Doses (60-70gy vs. >70Gy) in Locally Advanced Pancreatic Cancer

The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (60-70Gy Vs.>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

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: 021-31162222
  • Email: chyyzhj@163.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
        • Principal Investigator:
          • Huojun Zhang, M.D.
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18≤Age≤75 years
  • Cytologically or histologically verified pancreatic adenocarcinoma or clinically diagnosed as pancreatic cancer by multidisciplinary consultation
  • locally advanced pancreatic cancer (LAPC)
  • SBRT was not preceded by any targeted antitumor therapy
  • ECOG 0-1
  • Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures

Exclusion Criteria:

  • Patients who have previously received related treatment because of pancreatic adenocarcinoma, such as radiotherapy, chemotherapy or focal treatment
  • Patients with severe liver or kidney dysfunction
  • Patients with obstructive jaundice
  • Patients with mass ascites
  • Patients participated in other clinical trials for less than three months
  • Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, ect
  • Unsuitable to participate in this clinical trial judged by the investigator

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
SBRT with BED 60-70Gy combined with Gemcitabine + albumin-bound paclitaxel
Radiation: SBRT
SBRT: in 5-6 fractions with CyberKnife
Drug: Chemotherapy
1000 mg of Gemcitabine + albumin-bound paclitaxel per square meter of body surface area on days 1, 8 for 2 weeks, followed by 1 weeks of rest as one course
Experimental: Arm B
SBRT with BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel
Radiation: SBRT
SBRT: in 5-6 fractions with CyberKnife
Drug: Chemotherapy
1000 mg of Gemcitabine + albumin-bound paclitaxel per square meter of body surface area on days 1, 8 for 2 weeks, followed by 1 weeks of rest as one course

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year Disease Progression-Free-Survival (DPFS)
Time Frame: 1-year
Disease Progression-Free-Survival (DPFS)
1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Probability of gastrointestinal (GI) Toxicity
Time Frame: 1-year
gastrointestinal (GI) toxicity
1-year
1-year Local Control Rate
Time Frame: 1-year
Local Control Rate
1-year
Overall Survival
Time Frame: 1-year
Overall Survival
1-year

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Anticipated)

October 20, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Changhai Hospit

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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