Clincosm LogoSign in Get a demo

Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer

Sponsor
Shanghai Proton and Heavy Ion Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04082455
Collaborator
(none)
49
Enrollment
1
Location
1
Arm
56
Anticipated Duration (Months)
0.9
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 locally advanced pancreatic carcinoma (LAPC)

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

Detailed Description

The carbon dose of 60-67.5GyE 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 Locally Advanced Pancreatic Cancer
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

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. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time interval from the start of radiotherapy to 3 months after the completion of radiotherapy]

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

  1. overall survival rate [2 years]

    overall survival rate

  2. local progression-free survival [2 years]

    local progression-free survival

  3. progression-free survivals [2 years]

    progression-free survivals

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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, 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.

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:
NCT04082455
Other Study ID Numbers:
  • SPHIC-TR-PaCa2018-03
First Posted:
Sep 9, 2019
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
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
Additional relevant MeSH terms:
Pancreatic Neoplasms

Study Results

No Results Posted as of Nov 23, 2021