Phase
Condition
Digestive System Neoplasms
Pancreatic Cancer
Carcinoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The histologically or cytologically confirmed, or the clinically diagnosed by clinicaldiagnosis criterion proposed by Pancreatic Cancer Committee of Chinese Anti-CancerAssociation [15], which was based on evidences of (1). Typical symptoms of abdominaland/or back pain; (2). CA19-9 increased over the normal up limit; (3). A pancreaticmass shown on CT or MRI; and (4). SUV of PET-CT in mass increased compared to that innormal pancreas;
Unresectable LAPC defined by the criteria of (NCCN) guidelines (Version 1. 2013), orrefusal 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
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 TACEand 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 highenergy beam or which affect the dose in target volume;
Dose constrain of normal liver, digested system and other OAR could not reach theexpecting safe dose constrain;
The patient could not get benefit from proton or heavy ion radiotherapy in physician'sopinion;
Comitant diseases or affecters which could affect the proton or heavy ionradiotherapy;
Pregnancy(blood or urine β-HCG certified)or lactation;
Drug or alcohol abused;
HIV positive, including received anti-retrovirus treatment; chronic hepatitis B virusreplication stage; hepatitis C active stage; syphilis active stage;
HBV positive, hepatitis B virus replication stage, need to be treated with anti-virustreatment, 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,congestiveheart failure,myocardial infarction; 2)acute bacterial or systemic fungal infections; 3)exacerbation of chronic obstructive pulmonary disease ( COPD) or other respiratorysystem disease requiring hospitalization 4)hepatic function insufficiency or renalfunction 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 consentform;
no civil capability or limited civil capacity.
Study Design
Study Description
Connect with a study center
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai 201315
ChinaSite Not Available

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