Ppancreatic CancerNCT07242911
Study on Efficacy and Safety of VMAT Technique With Local Dose Escalation for Unresectable Pancreatic Cancer
An observational study of Ppancreatic Cancer, run by Chifeng Tumor Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the efficacy and safety of the Volumetric Modulated Arc Therapy (VMAT) dose sculpting technique combined with different radiotherapy doses (local dose escalation vs. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Ppancreatic Cancer
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Aug 2026
- Phase
- Observational
- 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 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: he study population consists of patients with locally advanced pancreatic cancer recruited from Chifeng Tumor Hospital between 2018 and 2026. Inclusion criteria include: pathological or PET-CT confirmed diagnosis, age 18-76 years, Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and no prior radiotherapy. Exclusion criteria are: concurrent other malignant tumors, severe liver/kidney dysfunction, inability to tolerate treatment, and unwillingness to cooperate with the study. Demographic and clinical characteristics such as age, gender, and disease stage will be recorded.
Who may be able to join
- Patients with locally advanced pancreatic cancer confirmed by pathological diagnosis or PET-CT.
- Patients who refuse surgery or are inoperable.
- No history of radiotherapy.
- Aged 18-76 years with a performance status score of 0-1.
Who cannot join
- Patients with other concurrent primary malignant tumors.
- Patients unable to tolerate radiotherapy.
- Patients who are unable or unwilling to cooperate with the study.
- Patients with severe dysfunction of vital organs such as liver and kidneys.
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
Chifeng Tumor Hospital
Chifeng, Inner Mongolia, 024000
Jiarui Zhang, +8615049640955, rad_zhangjiarui@163.com
About this study
The goal of this observational study is to learn about the efficacy and safety of the Volumetric Modulated Arc Therapy (VMAT) dose sculpting technique combined with different radiotherapy doses (local dose escalation vs. conventional dose) in patients with unresectable pancreatic cancer, with a focus on survival outcomes, tumor response, and toxic/adverse effects.
The main question it aims to answer is:Does the VMAT dose sculpting technique combined with local dose escalation radiotherapy (total dose 60-65Gy) improve overall survival (OS), progression-free survival (PFS), and tumor response rate while maintaining acceptable safety (i.e., manageable toxic/adverse effects) compared to conventional dose radiotherapy (total dose 45-50.4Gy) in patients with unresectable pancreatic cancer? Participants who have already received VMAT (as part of their regular medical care for unresectable pancreatic cancer) at Chifeng City Cancer Hospital from February 2018 to May 2026 will be divided into two groups based on the radiotherapy dose they received: the study group (local dose escalation, 60-65Gy) and the control group (conventional dose, 45-50.4Gy). All participants will undergo follow-up via phone calls, WeChat, and outpatient re-examinations to collect data on their survival status (OS, PFS), tumor response (assessed by RECIST 1.1 criteria), and toxic/adverse effects (assessed by RTOG for radiation injury and CTCAE 4.0 for chemotherapy-related reactions) until the completion of outcome evaluation.
- Conditions
- Ppancreatic Cancer
- Keywords
- Pancreatic Cancer, VMAT, Radiation Therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Group | Patients with unresectable pancreatic cancer receive Volumetric Modulated Arc Therapy (VMAT) with local dose escalation (total radiotherapy dose 60-65Gy) concurrent with capecitabine chemotherapy. | |
| Conventional Dose Group | Patients with unresectable pancreatic cancer receive conventional VMAT radiotherapy (total radiotherapy dose 45-50.4Gy) concurrent with capecitabine chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy
Time from study enrollment to death from any cause. Assessed via Kaplan-Meier survival analysis using SPSS 27.0, with survival status collected through phone, WeChat, and outpatient follow-up
Measured: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).
Secondary outcomes (3)
Progression-Free Survival (PFS) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy
Time from study enrollment to tumor progression (per RECIST 1.1 criteria) or death from any cause. Assessed via Kaplan-Meier analysis, with progression status determined by contrast-enhanced CT/MRI every 3 months during follow-up.
Measured: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).
Objective Response Rate (ORR) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy
Proportion of patients with complete response (CR) or partial response (PR) per RECIST 1.1 criteria. Assessed via contrast-enhanced CT/MRI at 1 month, 3 months, 6 months post-radiotherapy, and every 3 months thereafter, with independent review by two senior radiologists.
Measured: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).
Incidence of Chemoradiotherapy Toxicity and Adverse Effects in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherap
Incidence of grade ≥2 toxicities/adverse effects related to chemoradiotherapy, assessed by RTOG criteria for radiation injury and CTCAE v4.0 for chemotherapy reactions. Evaluated every 2 weeks during treatment and monthly for 3 months post-treatment, with group comparisons via chi-square test.
Measured: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ppancreatic CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chifeng Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242911
- Sponsor's protocol ID
- CFSZLYY-FLK-2025-002
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Efficacy and Safety of VMAT Technique With Local Dose Escalation for Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07242911
- Acronym / sponsor ID
- CFSZLYY-FLK-2025-002
- Conditions
- Ppancreatic Cancer
- Keywords
- Pancreatic Cancer, VMAT, Radiation Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chifeng Tumor HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 21 Nov 2025 (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 goal of this observational study is to learn about the efficacy and safety of the Volumetric Modulated Arc Therapy (VMAT) dose sculpting technique combined with different radiotherapy doses (local dose escalation vs. conventional dose) in patients with unresectable pancreatic cancer, with a focus on survival outcomes, tumor response, and toxic/adverse effects.
The main question it aims to answer is:Does the VMAT dose sculpting technique combined with local dose escalation radiotherapy (total dose 60-65Gy) improve overall survival (OS), progression-free survival (PFS), and tumor response rate while maintaining acceptable safety (i.e., manageable toxic/adverse effects) compared to conventional dose radiotherapy (total dose 45-50.4Gy) in patients with unresectable pancreatic cancer? Participants who have already received VMAT (as part of their regular medical care for unresectable pancreatic cancer) at Chifeng City Cancer Hospital from February 2018 to May 2026 will be divided into two groups based on the radiotherapy dose they received: the study group (local dose escalation, 60-65Gy) and the control group (conventional dose, 45-50.4Gy). All participants will undergo follow-up via phone calls, WeChat, and outpatient re-examinations to collect data on their survival status (OS, PFS), tumor response (assessed by RECIST 1.1 criteria), and toxic/adverse effects (assessed by RTOG for radiation injury and CTCAE 4.0 for chemotherapy-related reactions) until the completion of outcome evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Group | – | –Patients with unresectable pancreatic cancer receive Volumetric Modulated Arc Therapy (VMAT) with local dose escalation (total radiotherapy dose 60-65Gy) concurrent with capecitabine chemotherapy. |
| Conventional Dose Group | – | –Patients with unresectable pancreatic cancer receive conventional VMAT radiotherapy (total radiotherapy dose 45-50.4Gy) concurrent with capecitabine chemotherapy |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- he study population consists of patients with locally advanced pancreatic cancer recruited from Chifeng Tumor Hospital between 2018 and 2026. Inclusion criteria include: pathological or PET-CT confirmed diagnosis, age 18-76 years, Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and no prior radiotherapy. Exclusion criteria are: concurrent other malignant tumors, severe liver/kidney dysfunction, inability to tolerate treatment, and unwillingness to cooperate with the study. Demographic and clinical characteristics such as age, gender, and disease stage will be recorded.
Key inclusion criteria (4 listed)
- Patients with locally advanced pancreatic cancer confirmed by pathological diagnosis or PET-CT.
- Patients who refuse surgery or are inoperable.
- No history of radiotherapy.
- Aged 18-76 years with a performance status score of 0-1.
Key exclusion criteria (4 listed)
- Patients with other concurrent primary malignant tumors.
- Patients unable to tolerate radiotherapy.
- Patients who are unable or unwilling to cooperate with the study.
- Patients with severe dysfunction of vital organs such as liver and kidneys.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy
Time frame: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).
Time from study enrollment to death from any cause. Assessed via Kaplan-Meier survival analysis using SPSS 27.0, with survival status collected through phone, WeChat, and outpatient follow-up
3 secondary outcomes
Progression-Free Survival (PFS) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy
Time frame: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).
Objective Response Rate (ORR) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy
Time frame: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).
Incidence of Chemoradiotherapy Toxicity and Adverse Effects in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherap
Time frame: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).
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 21 Nov 2025.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ppancreatic Cancer, run by Chifeng Tumor 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 Nov 2025. 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 Jiarui Zhang (+8615049640955, rad_zhangjiarui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy (time frame: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).). 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 21 Nov 2025.