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Clinical Trial Record

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Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer

2015-05-01

2016-10-31

2016-10-31

10

Study Overview

Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer

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)

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.

  • Pancreatic Carcinoma
  • RADIATION: proton and carbon ion radiotherapy
  • SPHIC-TR-PaCa2015-10

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-05-07  

N/A  

2020-03-04  

2019-05-13  

N/A  

2020-03-05  

2019-05-14  

N/A  

2020-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: proton and carbon ion radiotherapy

proton and carbon ion radiotherapy

RADIATION: proton and carbon ion radiotherapy

  • proton and carbon ion radiotherapy
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0Number of participants with treatment-related adverse events as assessed by CTCAE v4.0Time interval from the start of radiotherapy to 3 months after the completion of radiotherapy
Secondary Outcome MeasuresMeasure DescriptionTime Frame
overall survival rateoverall survival rate2 years
local progression-free survivallocal progression-free survival2 years
progression-free survivalsprogression-free survivals2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. 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; 2. Unresectable LAPC defined by the criteria of (NCCN) guidelines (Version 1. 2013), or refusal to surgery; 3. Gastrointestinal tract (GI) not invaded; 4. ECOG Performance Status 0-1 within 30 days prior to registration; 5. Age of ≥ 18 years old; 6. Enough hematological function (white blood cell count ≥ 3.0×109/L; platelets ≥50×109/L; hemoglobin ≥ 90 g/L); 7. 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); 8. No evidence of distant metastases, based upon PET, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration; 9. Informed consent form obtained.
    Exclusion Criteria:
    1. No pathological evidence of malignant tumor; 2. ECOG>=2； 3. Liver, kidney and bone marrow function are poor and not adequate for treatment; 4. Side effect of previous treatment is not covered yet, eg. The interval between TACE and other anti-tumor therapy is less than one month; 5. Prior radiation therapy to the abdomen or radioactive particle implantation; 6. cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume; 7. Dose constrain of normal liver, digested system and other OAR could not reach the expecting safe dose constrain; 8. The patient could not get benefit from proton or heavy ion radiotherapy in physician's opinion; 9. Comitant diseases or affecters which could affect the proton or heavy ion radiotherapy; 10. Pregnancy（blood or urine β-HCG certified）or lactation; 11. Drug or alcohol abused; 12. HIV positive, including received anti-retrovirus treatment; chronic hepatitis B virus replication stage; hepatitis C active stage; syphilis active stage; 13. 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; 14. Psychiatric history, possibly affecting the completion of treatment; 15. 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 16. patients with connective tissue disease such as active scleroderma or lupus and so on, which is contraindication for radiotherapy 17. patients can't understand treatment goal or unwilling/unable to sign up inform consent form； 18. no civil capability or limited civil capacity.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: guoliang Jiang, Dr., Shanghai Proton and Heavy Ion Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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