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出境医 / 临床实验 / Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer

Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer

Study Description
Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Pancreatic Carcinoma Radiation: proton and carbon ion radiotherapy Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Proton and Carbon Ion Radiation Dose Escalation in Patients With Locally Advanced Pancreatic Cancer
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016
Arms and Interventions
Arm Intervention/treatment
Experimental: proton and carbon ion radiotherapy
proton and carbon ion radiotherapy
Radiation: proton and carbon ion radiotherapy
proton and carbon ion radiotherapy

Outcome Measures
Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 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 [ Time Frame: 2 years ]
    overall survival rate

  2. local progression-free survival [ Time Frame: 2 years ]
    local progression-free survival

  3. progression-free survivals [ Time Frame: 2 years ]
    progression-free survivals


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Locations
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China, Shanghai
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai, China, 201315
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
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Principal Investigator: guoliang Jiang, Dr. Shanghai Proton and Heavy Ion Center
Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date March 5, 2020
Actual Study Start Date  ICMJE May 1, 2015
Actual Primary Completion Date October 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • overall survival rate [ Time Frame: 2 years ]
    overall survival rate
  • local progression-free survival [ Time Frame: 2 years ]
    local progression-free survival
  • progression-free survivals [ Time Frame: 2 years ]
    progression-free survivals
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer
Official Title  ICMJE A Phase I Trial of Proton and Carbon Ion Radiation Dose Escalation in Patients With Locally Advanced Pancreatic Cancer
Brief Summary 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)
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Carcinoma
Intervention  ICMJE Radiation: proton and carbon ion radiotherapy
proton and carbon ion radiotherapy
Study Arms  ICMJE Experimental: proton and carbon ion radiotherapy
proton and carbon ion radiotherapy
Intervention: Radiation: proton and carbon ion radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2019)
9
Actual Study Completion Date  ICMJE October 31, 2016
Actual Primary Completion Date October 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949933
Other Study ID Numbers  ICMJE SPHIC-TR-PaCa2015-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Guoliang Jiang, Shanghai Proton and Heavy Ion Center
Study Sponsor  ICMJE Shanghai Proton and Heavy Ion Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: guoliang Jiang, Dr. Shanghai Proton and Heavy Ion Center
PRS Account Shanghai Proton and Heavy Ion Center
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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