Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery

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/A

Clinical Study ID

NCT05830019
SPHIC-TR-PaCa2021-01
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The histologically or cytologically confirmed pancreatic adenocarcinoma;
  2. 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;
  3. Eastern Cooperative Oncology Group Performance Status 0-1 within 30 days prior toregistration;
  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 xULN);
  7. Informed consent form obtained.

Exclusion

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 otherlocal treatment for the recurrent lesions;
  5. Cardiac pacemaker or other metal implantation whose function may be disturbed by highenergy beam or which affect the dose in target volume;
  6. Dose constrain of normal liver, digested system and other organ at risk could notreach the expecting safe dose constrain;
  7. The patient could not get benefit from proton or heavy ion radiotherapy in physician'sopinion;
  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 virusreplication stage; hepatitis C active stage; syphilis active stage;
  12. 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;
  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,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
  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 consentform;
  17. 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

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.

Connect with a study center

  • Shanghai Proton and Heavy Ion Center

    Shanghai, Shanghai 201315
    China

    Active - Recruiting

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