Pancreatic CarcinomaNCT03949933
Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer
A study testing proton and 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 proton and carbon ion radiotherapy (PCRT) for locally advanced pancreatic carcinoma (LAPC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma
- What is being tested?
- proton and carbon ion radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2015to 31 Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Unresectable LAPC defined by the criteria of (NCCN) guidelines (Version 1. 2013), or refusal to surgery;
- Gastrointestinal tract (GI) not invaded;
- ECOG 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);
Show all 9Show fewer
- 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);
- No evidence of distant metastases, based upon PET, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration;
- Informed consent form obtained.
Who cannot join
- No pathological evidence of malignant tumor;
- ECOG>=2；
- Liver, kidney and bone marrow function are poor and not adequate for treatment;
- Side effect of previous treatment is not covered yet, eg. The interval between TACE and other anti-tumor therapy is less than one month;
- Prior radiation therapy to the abdomen or radioactive particle implantation;
- cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume;
Show all 18Show fewer
- Dose constrain of normal liver, digested system and other OAR could not reach the expecting safe dose constrain;
- The patient could not get benefit from proton or heavy ion radiotherapy in physician's opinion;
- Comitant diseases or affecters which could affect the proton or heavy ion radiotherapy;
- Pregnancy（blood or urine β-HCG 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;
- 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;
- 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
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201315
About this study
Official title: A Phase I Trial of Proton and Carbon Ion Radiation Dose Escalation in Patients With Locally Advanced Pancreatic Cancer
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)
Read the 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.
- Conditions
- Pancreatic Carcinoma
- Being tested
- proton and carbon ion radiotherapy
- Keywords
- proton and carbon ion radiotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton and carbon ion radiotherapyRadiation
proton and carbon ion radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| proton and carbon ion radiotherapy | Experimental | proton and carbon ion radiotherapy Receives: Radiation: proton and carbon ion radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time interval from the start of radiotherapy to 3 months after the completion of radiotherapy
Secondary outcomes (3)
overall survival rate
overall survival rate
Measured: 2 years
local progression-free survival
local progression-free survival
Measured: 2 years
progression-free survivals
progression-free survivals
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 May 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
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
- 10 participants (actual)
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
- NCT03949933
- Sponsor's protocol ID
- SPHIC-TR-PaCa2015-10
- Status last verified
- Mar 2020
- First submitted
- 7 May 2019
- Last updated
- 5 Mar 2020
- 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 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Proton and Carbon Ion Radiation Dose Escalation in Patients With Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03949933
- Acronym / sponsor ID
- SPHIC-TR-PaCa2015-10
- Conditions
- Pancreatic Carcinoma
- Keywords
- proton and carbon ion radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 14 May 2019 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proton and carbon ion radiotherapy | Experimental | Radiation: proton and carbon ion radiotherapyproton and carbon ion radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- Unresectable LAPC defined by the criteria of (NCCN) guidelines (Version 1. 2013), or refusal to surgery;
- Gastrointestinal tract (GI) not invaded;
- ECOG Performance Status 0-1 within 30 days prior to registration;
- Age of ≥ 18 years old;
Key exclusion criteria (18 listed)
- No pathological evidence of malignant tumor;
- ECOG>=2；
- Liver, kidney and bone marrow function are poor and not adequate for treatment;
- Side effect of previous treatment is not covered yet, eg. The interval between TACE and other anti-tumor therapy is less than one month;
- Prior radiation therapy to the abdomen or radioactive particle implantation;
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 |
|---|---|---|
| proton and carbon ion radiotherapyproton and carbon ion radiotherapy | Radiation | proton and carbon ion radiotherapy |
Primary outcome
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
3 secondary outcomes
overall survival rate
Time frame: 2 years
local progression-free survival
Time frame: 2 years
progression-free survivals
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Carcinoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
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 proton and 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 5 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 5 Mar 2020.