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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiarui Zhang | Contact | +8615049640955 | rad_zhangjiarui@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chifeng Tumor Hospital | Chifeng | Inner Mongolia | 024000 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 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. | 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. | Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion). |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |