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The goal of this observational study is to learn about the therapeutic effects of chemoradiotherapy for older adults (age 70-85) with locally advanced pancreatic cancer. The main question it aims to answer is:
Does chemoradiotherapy represent an effective and safe treatment for older participants without radical surgery? Participants will sequentially receive combined chemotherapy followed by concurrent chemoradiotherapy and subsequent maintenance therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group |
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| Measure | Description | Time Frame |
|---|---|---|
| 1-year survival rate | To observe whether the 1-year survival rate of elderly patients with locally advanced pancreatic cancer treated with sandwich-like chemoradiotherapy modality was comparable to that of the historical data of the general adult population. | From the date of first therapy administration to one year later |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity and side effects and tolerability assessment | Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTCAE Version 5.0. | From the date of first therapy administration to within 90 days, up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with locally advanced pancreatic cancer who are evaluated by imaging at Shanghai Zhongshan hospital, aged between 70 and 85 years old, will be screened and enrolled after discussion by the ZSPAC multidisciplinary expert committee.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenquan Wang | Contact | +86 21 31587861 | wang.wenquan@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | China |
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| event-free survival throughout the enrolled subject population |
Survival time from the start of therapy administration to the date of first documented progression or the date of death |
| From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. |
| the proportion of participants that completed chemoradiotherapy | From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months. |
| the proportion ofparticipants that completed all planned courses | From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months. |
| Objective response rate (ORR) tumor target lesions in the entire subject population all planned courses | ORR is defined as the percentage of patients who achieve complete response (CR) or partial response (PR) based on the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. | From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. |
| Disease control rate (DCR) of tumor target lesions in the entire subject population all planned courses | DCR is defined as the percentage of patients who achieved CR, PR and stable disease (SD), and will be evaluated based on RECIST 1.1 and the irRECIST criteria. | From date of first therapy administration until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 24 months. |