Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Zheng Wang, Dr.
- Phone Number: +862138296666
- Email: zheng.wang@sphic.org.cn
Study Contact Backup
- Name: Zhan Yu, Dr.
- Phone Number: +862138296666
- Email: zhan.yu@sphic.org.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201315
- Shanghai Proton and Heavy Ion Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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, 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: carbon ion radiotherapy
|
carbon ion radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
|
Time interval from the start of radiotherapy to 3 months after the completion of radiotherapy
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overall survival rate
Time Frame: 2 years
|
overall survival rate
|
2 years
|
|
local progression-free survival
Time Frame: 2 years
|
local progression-free survival
|
2 years
|
|
progression-free survivals
Time Frame: 2 years
|
progression-free survivals
|
2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Guo-Liang Jiang, Dr., Shanghai Proton and Heavy Ion Center
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SPHIC-TR-PaCa2018-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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