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Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery

Primary Purpose

Pancreatic Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
carbon ion radiotherapy
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Carcinoma focused on measuring carbon ion radiotherapy, recurrent pancreatic cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The histologically or cytologically confirmed pancreatic adenocarcinoma; Local-regional recurrent pancreatic cancer post surgery, no evidence of distant metastases, based upon Positron Emission Tomography, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration; Eastern Cooperative Oncology Group Performance Status 0-1 within 30 days prior to registration; Age of ≥ 18 years old; Enough hematological function (white blood cell count ≥ 3.0×109/L; platelets ≥50×109/L; hemoglobin ≥ 90 g/L); Enough liver and kidney functions (creatinine <110gmol/L; urea nitrogen <7.1mmol/L; bilirubin < 1.5 x ULN, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN); Informed consent form obtained. Exclusion Criteria: Eastern Cooperative Oncology Group Performance Status >=2; Liver, kidney and bone marrow function are poor and not adequate for treatment; GI was invaded by recurrent lesions; Prior radiation therapy to the abdomen or radioactive particle implantation or other local treatment for the recurrent lesions; Cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume; Dose constrain of normal liver, digested system and other organ at risk could not reach the expecting safe dose constrain; The patient could not get benefit from proton or heavy ion radiotherapy in physician's opinion; Comitant diseases which could affect the proton or heavy ion radiotherapy; Pregnancy(blood or urine β-human chorionic gonadotropin certified)or lactation; Drug or alcohol abused; HIV positive, including received anti-retrovirus treatment; chronic hepatitis B virus replication stage; hepatitis C active stage; syphilis active stage; hepatitis B virus positive, hepatitis B virus replication stage, need to be treated with anti-virus treatment, but could not receive anti-virus treatment because of comitant disease; Psychiatric history, possibly affecting the completion of treatment; Patients with serious complications that might affect radiotherapy, including 1)unstable angina pectoris requiring hospitalization in the last 6 months,congestive heart failure,myocardial infarction; 2)acute bacterial or systemic fungal infections; 3)exacerbation of chronic obstructive pulmonary disease ( COPD) or other respiratory system disease requiring hospitalization 4)hepatic function insufficiency or renal function insufficiency 5) immunosuppressed patients patients with connective tissue disease such as active scleroderma or lupus and so on, which is contraindication for radiotherapy patients can't understand treatment goal or unwilling/unable to sign up inform consent form; no civil capability or limited civil capacity.

Sites / Locations

  • Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

carbon ion radiotherapy

Arm Description

carbon ion radiotherapy

Outcomes

Primary Outcome Measures

local progression-free survival
local progression-free survival

Secondary Outcome Measures

overall survival rate
overall survival rate
progression-free survival
progression-free survival
adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE

Full Information

First Posted
November 21, 2021
Last Updated
April 25, 2023
Sponsor
Shanghai Proton and Heavy Ion Center
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1. Study Identification

Unique Protocol Identification Number
NCT05830019
Brief Title
Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery
Official Title
Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the toxicity and tolerance of carbon ion radiotherapy for recurrent pancreatic carcinoma post surgery
Detailed Description
The carbon dose of 67.5 Gy equivalent in 15 fractions was delivered to clinical target volume (CTV). The dose limiting toxicity (DLT) was defined as CTCAE grade 3 or higher of non-hematological toxicity (G3). The acute and late toxicities, overall survival (OS), progression-free survival (PFS), local progression-free survival (LPFS) and distant metastasis-free survival (DMFS) were the endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma
Keywords
carbon ion radiotherapy, recurrent pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
carbon ion radiotherapy
Arm Type
Experimental
Arm Description
carbon ion radiotherapy
Intervention Type
Radiation
Intervention Name(s)
carbon ion radiotherapy
Intervention Description
carbon ion radiotherapy
Primary Outcome Measure Information:
Title
local progression-free survival
Description
local progression-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival rate
Description
overall survival rate
Time Frame
2 years
Title
progression-free survival
Description
progression-free survival
Time Frame
2 years
Title
adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The histologically or cytologically confirmed pancreatic adenocarcinoma; Local-regional recurrent pancreatic cancer post surgery, no evidence of distant metastases, based upon Positron Emission Tomography, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration; Eastern Cooperative Oncology Group Performance Status 0-1 within 30 days prior to registration; Age of ≥ 18 years old; Enough hematological function (white blood cell count ≥ 3.0×109/L; platelets ≥50×109/L; hemoglobin ≥ 90 g/L); Enough liver and kidney functions (creatinine <110gmol/L; urea nitrogen <7.1mmol/L; bilirubin < 1.5 x ULN, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN); Informed consent form obtained. Exclusion Criteria: Eastern Cooperative Oncology Group Performance Status >=2; Liver, kidney and bone marrow function are poor and not adequate for treatment; GI was invaded by recurrent lesions; Prior radiation therapy to the abdomen or radioactive particle implantation or other local treatment for the recurrent lesions; Cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume; Dose constrain of normal liver, digested system and other organ at risk could not reach the expecting safe dose constrain; The patient could not get benefit from proton or heavy ion radiotherapy in physician's opinion; Comitant diseases which could affect the proton or heavy ion radiotherapy; Pregnancy(blood or urine β-human chorionic gonadotropin certified)or lactation; Drug or alcohol abused; HIV positive, including received anti-retrovirus treatment; chronic hepatitis B virus replication stage; hepatitis C active stage; syphilis active stage; hepatitis B virus positive, hepatitis B virus replication stage, need to be treated with anti-virus treatment, but could not receive anti-virus treatment because of comitant disease; Psychiatric history, possibly affecting the completion of treatment; Patients with serious complications that might affect radiotherapy, including 1)unstable angina pectoris requiring hospitalization in the last 6 months,congestive heart failure,myocardial infarction; 2)acute bacterial or systemic fungal infections; 3)exacerbation of chronic obstructive pulmonary disease ( COPD) or other respiratory system disease requiring hospitalization 4)hepatic function insufficiency or renal function insufficiency 5) immunosuppressed patients patients with connective tissue disease such as active scleroderma or lupus and so on, which is contraindication for radiotherapy patients can't understand treatment goal or unwilling/unable to sign up inform consent form; no civil capability or limited civil capacity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Cai, Dr.
Phone
+862138296666
Email
xin.cai@sphic.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoliang Jiang, Dr.
Organizational Affiliation
Shanghai Proton and Heavy Ion Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201315
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Cai, Dr
Phone
+862138296666
Email
xin.cai@sphic.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery

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