Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Carcinoma
• Intervention / Treatment: Radiation: carbon ion radiotherapy

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

Contacts and Locations

• Study Contact: Name: Xin Cai, Dr.; Phone Number: +862138296666; Email: xin.cai@sphic.org.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201315
      • Recruiting
      • Shanghai Proton and Heavy Ion Center
      • Contact: Xin Cai, Dr; Phone Number: +862138296666; Email: xin.cai@sphic.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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
local progression-free survival	local progression-free survival	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	progression-free survival	2 years
overall survival rate	overall survival rate	2 years
adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE	3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: recurrent pancreatic cancer; 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-PaCa2021-01

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