Study on Efficacy and Safety of VMAT Technique With Local Dose Escalation for Unresectable Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ppancreatic Cancer. Basic parameters: 18 years — 76 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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).]
Secondary outcome measures (3)
- 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Chifeng Tumor Hospital — Chifeng
Identifiers
NCT: NCT07242911 · CFSZLYY-FLK-2025-002