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Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery

Sponsor
Shanghai Proton and Heavy Ion Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05830019
Collaborator
(none)
49
Enrollment
1
Location
1
Arm
43
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: carbon ion radiotherapy
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: carbon ion radiotherapy

carbon ion radiotherapy

Radiation: carbon ion radiotherapy
carbon ion radiotherapy

Outcome Measures

Primary Outcome Measures

  1. local progression-free survival [2 years]

    local progression-free survival

Secondary Outcome Measures

  1. overall survival rate [2 years]

    overall survival rate

  2. progression-free survival [2 years]

    progression-free survival

  3. adverse events [3 years]

    Number of participants with treatment-related adverse events as assessed by CTCAE

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Proton and Heavy Ion Center Shanghai Shanghai China 201315

Sponsors and Collaborators

  • Shanghai Proton and Heavy Ion Center

Investigators

  • Principal Investigator: Guoliang Jiang, Dr., Shanghai Proton and Heavy Ion Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guoliang Jiang, director of clinical technical committee, professor, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier:
NCT05830019
Other Study ID Numbers:
  • SPHIC-TR-PaCa2021-01
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guoliang Jiang, director of clinical technical committee, professor, Shanghai Proton and Heavy Ion Center
carbon ion radiotherapy
recurrent pancreatic cancer
Additional relevant MeSH terms:
Pancreatic Neoplasms

Study Results

No Results Posted as of Apr 26, 2023