Treatment Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 138 |
Est. completion date | October 1, 2023 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Changhai hospital | Shanghai | Shanghai |
China | Shanghai Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1-year Disease Progression-Free-Survival (DPFS) | Disease Progression-Free-Survival (DPFS) | 1-year | |
Secondary | The Probability of gastrointestinal (GI) Toxicity | gastrointestinal (GI) toxicity | 1-year | |
Secondary | 1-year Local Control Rate | Local Control Rate | 1-year | |
Secondary | Overall Survival | Overall Survival | 1-year |
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