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NCT Number: NCT07242911

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

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.

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Key information

Conditions

Ppancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiarui Zhang

CONTACT

[email protected]

+8615049640955

Sponsors and collaborators

Lead sponsor

Chifeng Tumor Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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