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

NCT ID: NCT07242911

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ppancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Conventional Dose Group

Patients with unresectable pancreatic cancer receive conventional VMAT radiotherapy (total radiotherapy dose 45-50.4Gy) concurrent with capecitabine chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chifeng Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chifeng Tumor Hospital

Chifeng, Inner Mongolia, China

Site Status

Countries

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China

Central Contacts

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Jiarui Zhang

Role: CONTACT

+8615049640955

Facility Contacts

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Jiarui Zhang

Role: primary

+8615049640955

Other Identifiers

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CFSZLYY-FLK-2025-002

Identifier Type: -

Identifier Source: org_study_id

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