Study on Efficacy and Safety of VMAT Technique With Local Dose Escalation for Unresectable Pancreatic Cancer

November 17, 2025 updated by: Chifeng Tumor Hospital

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 024000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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.
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).
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.
Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chifeng Tumor Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFSZLYY-FLK-2025-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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