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Clinical Trial Record

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Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery

2021-06-01

2024-12-31

2024-12-31

49

Study Overview

Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery

The aim of this study is to evaluate the toxicity and tolerance of carbon ion radiotherapy for recurrent pancreatic carcinoma post surgery

The carbon dose of 67.5 Gy equivalent in 15 fractions was delivered to clinical target volume (CTV). 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: carbon ion radiotherapy
  • SPHIC-TR-PaCa2021-01

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

2021-11-21  

N/A  

2023-04-25  

2023-04-25  

N/A  

2023-04-26  

2023-04-26  

N/A  

2023-04  

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: carbon ion radiotherapy

carbon ion radiotherapy

RADIATION: carbon ion radiotherapy

  • carbon ion radiotherapy
Primary Outcome MeasuresMeasure DescriptionTime Frame
local progression-free survivallocal progression-free survival2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
overall survival rateoverall survival rate2 years
progression-free survivalprogression-free survival2 years
adverse eventsNumber of participants with treatment-related adverse events as assessed by CTCAE3 years

Contacts and Locations

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

Study Contact

Name: Xin Cai, Dr.

Phone Number: +862138296666

Email: xin.cai@sphic.org.cn

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 pancreatic adenocarcinoma; 2. Local-regional recurrent pancreatic cancer post surgery, no evidence of distant metastases, based upon Positron Emission Tomography, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration; 3. Eastern Cooperative Oncology Group Performance Status 0-1 within 30 days prior to registration; 4. Age of ≥ 18 years old; 5. Enough hematological function (white blood cell count ≥ 3.0×109/L; platelets ≥50×109/L; hemoglobin ≥ 90 g/L); 6. 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 x ULN); 7. Informed consent form obtained.
    Exclusion Criteria:
    1. Eastern Cooperative Oncology Group Performance Status >=2； 2. Liver, kidney and bone marrow function are poor and not adequate for treatment; 3. GI was invaded by recurrent lesions; 4. Prior radiation therapy to the abdomen or radioactive particle implantation or other local treatment for the recurrent lesions; 5. Cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume; 6. Dose constrain of normal liver, digested system and other organ at risk could not reach the expecting safe dose constrain; 7. The patient could not get benefit from proton or heavy ion radiotherapy in physician's opinion; 8. Comitant diseases which could affect the proton or heavy ion radiotherapy; 9. Pregnancy（blood or urine β-human chorionic gonadotropin certified）or lactation; 10. Drug or alcohol abused; 11. HIV positive, including received anti-retrovirus treatment; chronic hepatitis B virus replication stage; hepatitis C active stage; syphilis active stage; 12. hepatitis B virus 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; 13. Psychiatric history, possibly affecting the completion of treatment; 14. 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 15. patients with connective tissue disease such as active scleroderma or lupus and so on, which is contraindication for radiotherapy 16. patients can't understand treatment goal or unwilling/unable to sign up inform consent form； 17. 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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