Pancreatic CancerPhase 2NCT06427460
Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)
A Phase 2 study testing Central-boost ablative dose delivered by stereotactic body radiation therapy in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Central-boost ablative dose delivered by stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2024to 31 Dec 2026
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years.
- Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.
- Oligometastasis in the case of metastatic tumor
- the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm
- ECOG of 0 to 1 point
- No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10^9/L, neutrophil count ≥2.0×10^9, hemoglobin level ≥100g/L, platelet count ≥100×10^9/L, ALT and AST level < 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio <2)
Who cannot join
- History of radiotherapy for the lesion
- History of tumor within 5 years
- ECOG ≥2 points
- Significant abnormality in blood routine test, liver and kidney function test and coagulation test
- Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor
- Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor
Show all 9Show fewer
- Infections required antibiotics
- Heart or respiratory insufficiency
- Pregnant or breastfeeding women
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
Huojun Zhang
Shanghai, Shanghai Municipality, 200433
Xiaofei Zhu, 86-021-31162222, zhuxiaofei_zxf@163.com
Huojun Zhang, M.D.
About this study
Official title: Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk
In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required.
Read the detailed description
Regarding the advanced stage tumor, especially tumors with large volumes or closely adjacent to organs at risk, patients are not candidates for surgical resection. Therefore, raduitherapy may be the optimal local therapy to ameliorate symptoms and be combined with systemic therapy, including chemotherapy, targeted therapy or immunotherapy. However, for those tumors, ablative doses could not be given due to large volumes and abutting to organs at risk.
In order to solve the problem, spatially fractionated radiation therapy (SFRT) is used. In details, it was performed based on grid or lattice, which creates several cylindrical high-radiation-dose areas in tumors. Nevertheless, the ablative dose areas are limited albeit with SFRT, which may not greatly improve tumor local. Hence, we create an inner and complete inner gross tumor volume that would be delivered ablative radiation doses, which is named as central-boost ablative radiation therapy (CBART). We aim to investigate the efficacy and safety of CBART in large tumors or tumors adjacent to organs at risk.
- Conditions
- Pancreatic Cancer
- Being tested
- Central-boost ablative dose delivered by stereotactic body radiation therapy
- Keywords
- pancreatic cancer, stereotactic body radiation therapy, inner gross tumor volume, central boost, ablative radiation dose
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central-boost ablative dose delivered by stereotactic body radiation therapyRadiation
An inner and complete gross tumor volume (iGTV) is created within the gross tumor volume (GTV). For the liver or lung tumor, the convetional radiation dose is 35-45Gy/5f. Regarding the pancreatic tumor or retroperitoneal tumor, the radiation dose is 30-40Gy/5f. Hence, the radiation dose of iGTV should not be less than 120% of the dose of GTV.
| Study group | Role | What they receive |
|---|---|---|
| stereotactic body radiation therapy | Experimental | Central-boost ablative doses delivered by SBRT. Receives: Radiation: Central-boost ablative dose delivered by stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year local control will be determined.
The proportion of patients without tumor local progression at one year. The progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 1 year
Secondary outcomes (3)
Overall survival will be determined.
The time from the enrollment to death.
Measured: 2 years
Progression free survival will be determined.
The time from the enrollment to documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 2 years
Treatment related adverse events
Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
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 posted23 May 2024
- Study start12 May 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Huo Jun, Changhai Hospital
- Investigators
- Huojun Zhang, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427460
- Sponsor's protocol ID
- Changhai Hospital NMU
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 23 May 2024
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk
- ClinicalTrials.gov ID
- NCT06427460
- Acronym / sponsor ID
- Changhai Hospital NMU
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, stereotactic body radiation therapy, inner gross tumor volume, central boost, ablative radiation dose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 12 May 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 May 2024 (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.
In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required.
Detailed description
Regarding the advanced stage tumor, especially tumors with large volumes or closely adjacent to organs at risk, patients are not candidates for surgical resection. Therefore, raduitherapy may be the optimal local therapy to ameliorate symptoms and be combined with systemic therapy, including chemotherapy, targeted therapy or immunotherapy. However, for those tumors, ablative doses could not be given due to large volumes and abutting to organs at risk.
In order to solve the problem, spatially fractionated radiation therapy (SFRT) is used. In details, it was performed based on grid or lattice, which creates several cylindrical high-radiation-dose areas in tumors. Nevertheless, the ablative dose areas are limited albeit with SFRT, which may not greatly improve tumor local. Hence, we create an inner and complete inner gross tumor volume that would be delivered ablative radiation doses, which is named as central-boost ablative radiation therapy (CBART). We aim to investigate the efficacy and safety of CBART in large tumors or tumors adjacent to organs at risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stereotactic body radiation therapy | Experimental | Radiation: Central-boost ablative dose delivered by stereotactic body radiation therapyCentral-boost ablative doses delivered by SBRT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75 years.
- Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.
- Oligometastasis in the case of metastatic tumor
- the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm
- ECOG of 0 to 1 point
Key exclusion criteria (9 listed)
- History of radiotherapy for the lesion
- History of tumor within 5 years
- ECOG ≥2 points
- Significant abnormality in blood routine test, liver and kidney function test and coagulation test
- Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor
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 |
|---|---|---|
| Central-boost ablative dose delivered by stereotactic body radiation therapyAn inner and complete gross tumor volume (iGTV) is created within the gross tumor volume (GTV). For the liver or lung tumor, the convetional radiation dose is 35-45Gy/5f. Regarding the pancreatic tumor or retroperitoneal tumor, the radiation dose is 30-40Gy/5f. Hence, the radiation dose of iGTV should not be less than 120% of the dose of GTV. | Radiation | stereotactic body radiation therapy |
Primary outcome
One-year local control will be determined.
Time frame: 1 year
The proportion of patients without tumor local progression at one year. The progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
3 secondary outcomes
Overall survival will be determined.
Time frame: 2 years
Progression free survival will be determined.
Time frame: 2 years
Treatment related adverse events
Time frame: 2 years
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 23 May 2024.
- 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.
Huojun Zhang, M.D. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Central-boost ablative dose delivered by stereotactic body radiation therapy in people with Pancreatic Cancer, run by Changhai Hospital 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 6 inclusion and 9 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 23 May 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaofei Zhu (86-021-31162222, zhuxiaofei_zxf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year local control will be determined. (time frame: 1 year). 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 23 May 2024.