Pancreatic CarcinomaNCT05830019
Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery
A study testing carbon ion radiotherapy in people with Pancreatic Carcinoma, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
The aim of this study is to evaluate the toxicity and tolerance of carbon ion radiotherapy for recurrent pancreatic carcinoma post surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Carcinoma
- What is being tested?
- carbon ion radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The histologically or cytologically confirmed pancreatic adenocarcinoma;
- 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;
- Eastern Cooperative Oncology Group Performance Status 0-1 within 30 days prior to registration;
- Age of ≥ 18 years old;
- Enough hematological function (white blood cell count ≥ 3.0×109/L; platelets ≥50×109/L; hemoglobin ≥ 90 g/L);
- 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);
- Informed consent form obtained.
Who cannot join
- Eastern Cooperative Oncology Group Performance Status >=2；
- Liver, kidney and bone marrow function are poor and not adequate for treatment;
- GI was invaded by recurrent lesions;
- Prior radiation therapy to the abdomen or radioactive particle implantation or other local treatment for the recurrent lesions;
- Cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume;
- Dose constrain of normal liver, digested system and other organ at risk could not reach the expecting safe dose constrain;
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- The patient could not get benefit from proton or heavy ion radiotherapy in physician's opinion;
- Comitant diseases which could affect the proton or heavy ion radiotherapy;
- Pregnancy（blood or urine β-human chorionic gonadotropin certified）or lactation;
- Drug or alcohol abused;
- HIV positive, including received anti-retrovirus treatment; chronic hepatitis B virus replication stage; hepatitis C active stage; syphilis active stage;
- 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;
- Psychiatric history, possibly affecting the completion of treatment;
- 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
- patients with connective tissue disease such as active scleroderma or lupus and so on, which is contraindication for radiotherapy
- patients can't understand treatment goal or unwilling/unable to sign up inform consent form；
- no civil capability or limited civil capacity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201315
Xin Cai, Dr, +862138296666, xin.cai@sphic.org.cn
About this study
The aim of this study is to evaluate the toxicity and tolerance of carbon ion radiotherapy for recurrent pancreatic carcinoma post surgery
Read the 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.
- Conditions
- Pancreatic Carcinoma
- Being tested
- carbon ion radiotherapy
- Keywords
- carbon ion radiotherapy, recurrent pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon ion radiotherapyRadiation
carbon ion radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| carbon ion radiotherapy | Experimental | carbon ion radiotherapy Receives: Radiation: carbon ion radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local progression-free survival
local progression-free survival
Measured: 2 years
Secondary outcomes (3)
overall survival rate
overall survival rate
Measured: 2 years
progression-free survival
progression-free survival
Measured: 2 years
adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Jun 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoliang Jiang, Shanghai Proton and Heavy Ion Center
- Investigators
- Guoliang Jiang, Dr., Principal investigator, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830019
- Sponsor's protocol ID
- SPHIC-TR-PaCa2021-01
- Status last verified
- Apr 2023
- First submitted
- 21 Nov 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery
- ClinicalTrials.gov ID
- NCT05830019
- Acronym / sponsor ID
- SPHIC-TR-PaCa2021-01
- Conditions
- Pancreatic Carcinoma
- Keywords
- carbon ion radiotherapy, recurrent pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carbon ion radiotherapy | Experimental | Radiation: carbon ion radiotherapycarbon ion radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The histologically or cytologically confirmed pancreatic adenocarcinoma;
- 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;
- Eastern Cooperative Oncology Group Performance Status 0-1 within 30 days prior to registration;
- Age of ≥ 18 years old;
- Enough hematological function (white blood cell count ≥ 3.0×109/L; platelets ≥50×109/L; hemoglobin ≥ 90 g/L);
Key exclusion criteria (17 listed)
- Eastern Cooperative Oncology Group Performance Status >=2；
- Liver, kidney and bone marrow function are poor and not adequate for treatment;
- GI was invaded by recurrent lesions;
- Prior radiation therapy to the abdomen or radioactive particle implantation or other local treatment for the recurrent lesions;
- Cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbon ion radiotherapycarbon ion radiotherapy | Radiation | carbon ion radiotherapy |
Primary outcome
local progression-free survival
Time frame: 2 years
local progression-free survival
3 secondary outcomes
overall survival rate
Time frame: 2 years
progression-free survival
Time frame: 2 years
adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoliang Jiang, Dr. principal investigator
Shanghai Proton and Heavy Ion Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon ion radiotherapy in people with Pancreatic Carcinoma, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Cai, Dr. (+862138296666, xin.cai@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.