To hear about similar clinical trials, please enter your email below
Trial Title:
Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery
NCT ID:
NCT05830019
Condition:
Pancreatic Carcinoma
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
carbon ion radiotherapy
recurrent pancreatic cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
carbon ion radiotherapy
Description:
carbon ion radiotherapy
Arm group label:
carbon ion radiotherapy
Summary:
The aim of this study is to evaluate the toxicity and tolerance of carbon ion
radiotherapy for recurrent pancreatic carcinoma post surgery
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Proton and Heavy Ion Center
Address:
City:
Shanghai
Zip:
201315
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Cai, Dr
Phone:
+862138296666
Email:
xin.cai@sphic.org.cn
Start date:
June 1, 2021
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shanghai Proton and Heavy Ion Center
Agency class:
Other
Source:
Shanghai Proton and Heavy Ion Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05830019
