Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses

Study Overview
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Brief Summary
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The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (60-70Gy Vs.>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.

Official Title
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A Prospective Phase Ⅱ Clinical Study of Stereotactic Radiotherapy Combined With Chemotherapy With Different Biological Effective Doses (60-70gy vs. >70Gy) in Locally Advanced Pancreatic Cancer

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: 18≤Age≤75 years Cytologically or histologically verified pancreatic adenocarcinoma or clinically diagnosed as pancreatic cancer by multidisciplinary consultation locally advanced pancreatic cancer (LAPC) SBRT was not preceded by any targeted antitumor therapy ECOG 0-1 Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures Exclusion Criteria: Patients who have previously received related treatment because of pancreatic adenocarcinoma, such as radiotherapy, chemotherapy or focal treatment Patients with severe liver or kidney dysfunction Patients with obstructive jaundice Patients with mass ascites Patients participated in other clinical trials for less than three months Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, ect Unsuitable to participate in this clinical trial judged by the investigator

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>SBRT with BED 60-70Gy combined with Gemcitabine + albumin-bound paclitaxel | Radiation: SBRT<br>* SBRT: in 5-6 fractions with CyberKnife<br>Drug: Chemotherapy<br>* 1000 mg of Gemcitabine + albumin-bound paclitaxel per square meter of body surface area on days 1, 8 for 2 weeks, followed by 1 weeks of rest as one course<br>|
| Experimental: Arm B<br>SBRT with BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel | Radiation: SBRT<br>* SBRT: in 5-6 fractions with CyberKnife<br>Drug: Chemotherapy<br>* 1000 mg of Gemcitabine + albumin-bound paclitaxel per square meter of body surface area on days 1, 8 for 2 weeks, followed by 1 weeks of rest as one course<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year Disease Progression-Free-Survival (DPFS) | Disease Progression-Free-Survival (DPFS) | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Probability of gastrointestinal (GI) Toxicity | gastrointestinal (GI) toxicity | 1-year | 
| 1-year Local Control Rate | Local Control Rate | 1-year | 
| Overall Survival | 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, Biological Effective Dose