Last updated: April 25, 2023
Sponsor: Shanghai Proton and Heavy Ion Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pancreatic Cancer
Digestive System Neoplasms
Carcinoma
Treatment
N/AClinical Study ID
NCT05830019
SPHIC-TR-PaCa2021-01
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The histologically or cytologically confirmed pancreatic adenocarcinoma;
- Local-regional recurrent pancreatic cancer post surgery, no evidence of distantmetastases, 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 toregistration;
- 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 xULN);
- Informed consent form obtained.
Exclusion
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 otherlocal treatment for the recurrent lesions;
- 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 organ at risk could notreach the expecting safe dose constrain;
- The patient could not get benefit from proton or heavy ion radiotherapy in physician'sopinion;
- 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 virusreplication stage; hepatitis C active stage; syphilis active stage;
- hepatitis B virus positive, hepatitis B virus replication stage, need to be treatedwith anti-virus treatment, but could not receive anti-virus treatment because ofcomitant 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
Total Participants: 49
Study Start date:
June 01, 2021
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai 201315
ChinaActive - Recruiting

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