Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
proton and carbon ion radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Carcinoma focused on measuring proton and carbon ion radiotherapy
Eligibility Criteria
Inclusion Criteria:
- The histologically or cytologically confirmed, or the clinically diagnosed by clinical diagnosis criterion proposed by Pancreatic Cancer Committee of Chinese Anti-Cancer Association [15], which was based on evidences of (1). Typical symptoms of abdominal and/or back pain; (2). CA19-9 increased over the normal up limit; (3). A pancreatic mass shown on CT or MRI; and (4). SUV of PET-CT in mass increased compared to that in normal pancreas;
- Unresectable LAPC defined by the criteria of (NCCN) guidelines (Version 1. 2013), or refusal to surgery;
- Gastrointestinal tract (GI) not invaded;
- ECOG 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, ALT and AST ≤ 2.5 x ULN);
- No evidence of distant metastases, based upon PET, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration;
- Informed consent form obtained.
Exclusion Criteria:
- No pathological evidence of malignant tumor;
- ECOG>=2;
- Liver, kidney and bone marrow function are poor and not adequate for treatment;
- Side effect of previous treatment is not covered yet, eg. The interval between TACE and other anti-tumor therapy is less than one month;
- Prior radiation therapy to the abdomen or radioactive particle implantation;
- 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 OAR 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 or affecters which could affect the proton or heavy ion radiotherapy;
- Pregnancy(blood or urine β-HCG 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;
- HBV 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 Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
proton and carbon ion radiotherapy
Arm Description
proton and carbon ion radiotherapy
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary Outcome Measures
overall survival rate
overall survival rate
local progression-free survival
local progression-free survival
progression-free survivals
progression-free survivals
Full Information
NCT ID
NCT03949933
First Posted
May 7, 2019
Last Updated
March 4, 2020
Sponsor
Shanghai Proton and Heavy Ion Center
1. Study Identification
Unique Protocol Identification Number
NCT03949933
Brief Title
Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer
Official Title
A Phase I Trial of Proton and Carbon Ion Radiation Dose Escalation in Patients With Locally Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
October 31, 2016 (Actual)
Study Completion Date
October 31, 2016 (Actual)
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 proton and carbon ion radiotherapy (PCRT) for locally advanced pancreatic carcinoma (LAPC)
Detailed Description
The proton dose of 50.4GyE in 28 fractions was delivered to clinical target volume (CTV), and carbon ion as a boost dose to gross tumor volume (GTV) escalated from 12GyE to 18GyE with 3GyE per fraction in 3 dose levels. 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
proton and carbon ion radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
proton and carbon ion radiotherapy
Arm Type
Experimental
Arm Description
proton and carbon ion radiotherapy
Intervention Type
Radiation
Intervention Name(s)
proton and carbon ion radiotherapy
Intervention Description
proton and carbon ion radiotherapy
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Time interval from the start of radiotherapy to 3 months after the completion of radiotherapy
Secondary Outcome Measure Information:
Title
overall survival rate
Description
overall survival rate
Time Frame
2 years
Title
local progression-free survival
Description
local progression-free survival
Time Frame
2 years
Title
progression-free survivals
Description
progression-free survivals
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The histologically or cytologically confirmed, or the clinically diagnosed by clinical diagnosis criterion proposed by Pancreatic Cancer Committee of Chinese Anti-Cancer Association [15], which was based on evidences of (1). Typical symptoms of abdominal and/or back pain; (2). CA19-9 increased over the normal up limit; (3). A pancreatic mass shown on CT or MRI; and (4). SUV of PET-CT in mass increased compared to that in normal pancreas;
Unresectable LAPC defined by the criteria of (NCCN) guidelines (Version 1. 2013), or refusal to surgery;
Gastrointestinal tract (GI) not invaded;
ECOG 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, ALT and AST ≤ 2.5 x ULN);
No evidence of distant metastases, based upon PET, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration;
Informed consent form obtained.
Exclusion Criteria:
No pathological evidence of malignant tumor;
ECOG>=2;
Liver, kidney and bone marrow function are poor and not adequate for treatment;
Side effect of previous treatment is not covered yet, eg. The interval between TACE and other anti-tumor therapy is less than one month;
Prior radiation therapy to the abdomen or radioactive particle implantation;
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 OAR 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 or affecters which could affect the proton or heavy ion radiotherapy;
Pregnancy(blood or urine β-HCG 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;
HBV 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.
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer
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