Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of two target delineation methods in SBRT for LAPC, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.

Official Title
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GTV Uniform Expansion to Form PTV vs. Non-uniform Expansion to Form PTV Based on Recurrence Pattern in SBRT of Locally Advanced Pancreatic Cancer: a Phase II Clinical Prospective Study

Conditions
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Treatment

Intervention / Treatment
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* Radiation: SBRT
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 Patients with a pathological diagnosis of pancreatic ductal adenocarcinoma or clinical diagnosis of pancreatic cancer after clinical multiple disciplinary team Patients with a clinical staging of locally advanced pancreatic cancer No anti-tumor treatment related to pancreas before SBRT Performance status is acceptable, ECOG score is 0 or 1 Patients who voluntarily accepted the clinical trial program after informing the existing treatment plan Exclusion Criteria: Patients who have previously received relevant treatments in the pancreas and its surrounding areas, such as radiotherapy, chemotherapy, and local treatment Severe liver and kidney dysfunction Obstructive jaundice Moderate or mass ascites Patients with other malignant tumors, acute infection or other severe infection Patients with gastrointestinal ulcers and incomplete recovery, or patients with acute peptic ulcer Gastroscopy or imaging examination indicates that the tumor invaded the duodenum or stomach Patients who have participated in other clinical trials for less than three months Patients who are judged by researchers as unsuitable for this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>GTV uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1. | Radiation: SBRT<br>* SBRT: in 5-6fractions with Cyberknife.<br>Drug: Chemotherapy<br>* Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8) or single-agent oral S-1 (60-120 mg/ daily, d1-14) , repeat every 3 weeks.<br>|
| Experimental: Arm B<br>GTV non-uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1. | Radiation: SBRT<br>* SBRT: in 5-6fractions with Cyberknife.<br>Drug: Chemotherapy<br>* Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8) or single-agent oral S-1 (60-120 mg/ daily, d1-14) , repeat every 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year Local Control Rate (1y-LCR) | Local Control Rate | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Probability of gastrointestinal (GI) Toxicity | gastrointestinal toxicity | 1-year | 
| 1-year Disease Progression-Free-Survival (DPFS) | Disease Progression-Free-Survival | 1-year | 
| Overall Survival(OS) | Overall Survival | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBRT, Locally Advanced Pancreatic Cancer, Target Delineation