search
Back to results

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

Primary Purpose

Treatment

Status
Unknown status
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, Biological Effective Dose

Eligibility Criteria

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

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

Sites / Locations

  • Changhai hospitalRecruiting
  • Shanghai Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

SBRT with BED 60-70Gy combined with Gemcitabine + albumin-bound paclitaxel

SBRT with BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel

Outcomes

Primary Outcome Measures

1-year Disease Progression-Free-Survival (DPFS)
Disease Progression-Free-Survival (DPFS)

Secondary Outcome Measures

The Probability of gastrointestinal (GI) Toxicity
gastrointestinal (GI) toxicity
1-year Local Control Rate
Local Control Rate
Overall Survival
Overall Survival

Full Information

First Posted
October 15, 2020
Last Updated
October 27, 2020
Sponsor
Changhai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04603586
Brief Title
Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2020 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2023 (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 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.

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, Biological Effective Dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
SBRT with BED 60-70Gy combined with Gemcitabine + albumin-bound paclitaxel
Arm Title
Arm B
Arm Type
Experimental
Arm Description
SBRT with BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
SBRT: in 5-6 fractions with CyberKnife
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
1-year Disease Progression-Free-Survival (DPFS)
Description
Disease Progression-Free-Survival (DPFS)
Time Frame
1-year
Secondary Outcome Measure Information:
Title
The Probability of gastrointestinal (GI) Toxicity
Description
gastrointestinal (GI) toxicity
Time Frame
1-year
Title
1-year Local Control Rate
Description
Local Control Rate
Time Frame
1-year
Title
Overall Survival
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huojun Zhang, M.D.
Phone
021-31162222
Email
chyyzhj@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yusheng Ye, M.D.
Phone
021-31162222
Email
yusheng97y@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.
Facility Name
Shanghai 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
021-31162222
Email
chyyzhj@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36038164
Citation
Ye Y, Zhu X, Zhao X, Jiang L, Cao Y, Zhang H. Biologically effective doses of 60-70Gy versus >70Gy of stereotactic body radiotherapy (SBRT) combined with chemotherapy in locally advanced pancreatic cancer: protocol of a single-centre, phase II clinical trial. BMJ Open. 2022 Aug 29;12(8):e049382. doi: 10.1136/bmjopen-2021-049382.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs