Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer

The aim of this study is to evaluate the toxicity and tolerance of carbon ion radiotherapy for locally advanced pancreatic carcinoma (LAPC)

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Carcinoma
• Intervention / Treatment: Radiation: carbon ion radiotherapy

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 Type: Interventional
• Enrollment (Estimated): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201315
      • Shanghai Proton and Heavy Ion Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: carbon ion radiotherapy	Radiation: carbon ion radiotherapy; carbon ion radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival rate	overall survival rate	2 years
local progression-free survival	local progression-free survival	2 years
progression-free survivals	progression-free survivals	2 years

Collaborators and Investigators

• Sponsor: Shanghai Proton and Heavy Ion Center
• Investigators: Principal Investigator: Guo-Liang Jiang, Dr., Shanghai Proton and Heavy Ion Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: carbon ion radiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: SPHIC-TR-PaCa2018-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No