Pancreatic Cancer Non-resectableNCT05424159
Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer
A study testing Carbon ion radiotherapy in people with Pancreatic Cancer Non-resectable, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- 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
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Have the ability to sign the written informed consent;
- Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology;
- Distant metastasis was excluded by imaging assessment (PET-CT, cranial MRI), and was defined as locally advanced unresectable according to NCCN Guidelines Version 2022.1, that is, T4N0-2M0, Stage III (AJCC/UICC Version 8);
- The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm;
- Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine);
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
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- Adequate bone marrow function (neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥10.0g/dL);
- Adequate liver function (total bilirubin <1.5 times the upper limit of normal value, aminotransferase <2.5 times the upper limit of normal value);
- Adequate renal function (serum creatinine <2mg/dL, or creatinine clearance >50mL/min).
Who cannot join
- Multiple primary pancreatic lesions (>1);
- Tumor invaded the adjacent digestive tract;
- Radiation therapy history;
- Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;
- The irradiation dose of organs at risk cannot reach the dose constraint;
- Other malignant tumors history;
- Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Proton and Heavy Ion Center
Shanghai, 201315
Zheng Wang, MD, +86-02138296666 ext. 53407, zheng.wang@sphic.org.cn
Guo-Liang Jiang, MD, 8621 38296606, guoliang.jiang@sphic.org.cn
About this study
Official title: Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer
The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.
Read the detailed description
The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer using pencil beam scanning and simultaneous integrated boost technology with respect to toxicity and tumor control. All enrolled patients will receive carbon ion radiotherapy for the primary pancreatic lesions, positive lymph nodes, and retroperitoneal high-risk recurrence areas. The prescription dose for primary pancreatic lesion, positive lymph node, and retroperitoneal high-risk recurrence area is 67.5 Gy (RBE weighted dose) in 15 fractions for 3 weeks; Pancreatic primary lesion and positive lymph node SIB to 75 Gy (RBE weighted dose) in 15 fractions for 3 weeks. The primary endpoint is 2-year cumulative local regional progression rate (LRP), and the secondary endpoint is to assess the overall survival (OS) and toxicities. Toxicity was assessed using the Common Adverse Event Evaluation Criteria (CTCAE) Version 5.0, and safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT).
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- Carbon ion radiotherapy
- Keywords
- Locally advanced unresectable pancreatic cancer, Carbon ion radiotherapy, Phase II clinical trial, Ablative dose, Optimized linear energy transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon ion radiotherapyRadiation
Patients with locally advanced unresectable pancreatic cancer without invasion of gastrointestinal tract will received ablative carbon ion radiotherapy. The prescription dose for primary pancreatic lesion, positive lymph node, and retroperitoneal high-risk recurrence area is 67.5 Gy (RBE weighted dose) in 15 fractions for 3 weeks; Pancreatic primary lesion and positive lymph node SIB to 75 Gy (RBE weighted dose) in 15 fractions for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patients with locally advanced unresectable pancreatic cancer | Experimental | Patients with locally advanced unresectable pancreatic cancer without invasion of the gastrointestinal tract, cT4N0-2M0 Stage III (AJCC/UICC Version 8). Receives: Radiation: Carbon ion radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year cumulative local regional progression rate (LRP)
LRP was defined as the percentage of patients with local disease progression (within irradiated area) in the intentional population.
Measured: From the date of the initiation of radiotherapy until the date of first documented occurrence of local regional progression, assessed up to 24 months.
Secondary outcomes (3)
2-year Overall survival (OS)
OS was defined as the percentage of patients dead in the intentional population.
Measured: From the date of diagnosis until the date of death from any cause, assessed up to 24 months.
Acute toxicity
Toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT).
Measured: From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy.
Late toxicity
Toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT).
Measured: 3 months after radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jul 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies 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
- Model description
- Radiation: carbon ion radiotherapy for tumors without invasion of GI
- Masking
- None (open label)
- Enrolment
- 48 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
- Zheng Wang, MD, PhD, Principal investigator, Shanghai Proton and Heavy Ion CenterXin Cai, MD, Principal investigator, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424159
- Sponsor's protocol ID
- SPHIC-TR-PaCa2022-01
- Status last verified
- Jun 2023
- First submitted
- 10 Jun 2022
- Last updated
- 7 Dec 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 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05424159
- Acronym / sponsor ID
- SPHIC-TR-PaCa2022-01
- Conditions
- Pancreatic Cancer Non-resectable
- Keywords
- Locally advanced unresectable pancreatic cancer, Carbon ion radiotherapy, Phase II clinical trial, Ablative dose, Optimized linear energy transfer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jun 2022 (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 investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.
Detailed description
The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer using pencil beam scanning and simultaneous integrated boost technology with respect to toxicity and tumor control. All enrolled patients will receive carbon ion radiotherapy for the primary pancreatic lesions, positive lymph nodes, and retroperitoneal high-risk recurrence areas. The prescription dose for primary pancreatic lesion, positive lymph node, and retroperitoneal high-risk recurrence area is 67.5 Gy (RBE weighted dose) in 15 fractions for 3 weeks; Pancreatic primary lesion and positive lymph node SIB to 75 Gy (RBE weighted dose) in 15 fractions for 3 weeks. The primary endpoint is 2-year cumulative local regional progression rate (LRP), and the secondary endpoint is to assess the overall survival (OS) and toxicities. Toxicity was assessed using the Common Adverse Event Evaluation Criteria (CTCAE) Version 5.0, and safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiation: carbon ion radiotherapy for tumors without invasion of GI
| Arm | Type | Receives |
|---|---|---|
| Patients with locally advanced unresectable pancreatic cancer | Experimental | Radiation: Carbon ion radiotherapyPatients with locally advanced unresectable pancreatic cancer without invasion of the gastrointestinal tract, cT4N0-2M0 Stage III (AJCC/UICC Version 8). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have the ability to sign the written informed consent;
- Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology;
- Distant metastasis was excluded by imaging assessment (PET-CT, cranial MRI), and was defined as locally advanced unresectable according to NCCN Guidelines Version 2022.1, that is, T4N0-2M0, Stage III (AJCC/UICC Version 8);
- The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm;
- Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine);
Key exclusion criteria (7 listed)
- Multiple primary pancreatic lesions (>1);
- Tumor invaded the adjacent digestive tract;
- Radiation therapy history;
- Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;
- The irradiation dose of organs at risk cannot reach the dose constraint;
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 radiotherapyPatients with locally advanced unresectable pancreatic cancer without invasion of gastrointestinal tract will received ablative carbon ion radiotherapy. The prescription dose for primary pancreatic lesion, positive lymph node, and retroperitoneal high-risk recurrence area is 67.5 Gy (RBE weighted dose) in 15 fractions for 3 weeks; Pancreatic primary lesion and positive lymph node SIB to 75 Gy (RBE weighted dose) in 15 fractions for 3 weeks. | Radiation | Patients with locally advanced unresectable pancreatic cancer |
Primary outcome
2-year cumulative local regional progression rate (LRP)
Time frame: From the date of the initiation of radiotherapy until the date of first documented occurrence of local regional progression, assessed up to 24 months.
LRP was defined as the percentage of patients with local disease progression (within irradiated area) in the intentional population.
3 secondary outcomes
2-year Overall survival (OS)
Time frame: From the date of diagnosis until the date of death from any cause, assessed up to 24 months.
Acute toxicity
Time frame: From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy.
Late toxicity
Time frame: 3 months after radiotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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.
Zheng Wang, MD, PhD principal investigator
Shanghai Proton and Heavy Ion Center
Xin Cai, MD 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 Cancer Non-resectable, 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 7 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: looking for participants now, as of the sponsor's last update on 7 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Wang, MD, PhD (+86-02138296666 ext. 53407, zheng.wang@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year cumulative local regional progression rate (LRP) (time frame: From the date of the initiation of radiotherapy until the date of first documented occurrence of local regional progression, assessed up to 24 months.). 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 7 Dec 2023.