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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) (<70Gy Vs.>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | SBRT of BED<70Gy combined with Gemcitabine + albumin-bound paclitaxel |
|
| Arm B | Experimental | SBRT of BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | SBRT: in 5-6 fractions with CyberKnife |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival | Progression-Free-Survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events | 3 years |
| Overall Survival | Overall Survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hospital | Shanghai | Shanghai Municipality | 200433 | China | ||
| Shanghai Changhai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36038164 | Derived | Ye Y, Zhu X, Zhao X, Jiang L, Cao Y, Zhang H. Biologically effective doses of 60-70Gy versus >70Gy of stereotactic body radiotherapy (SBRT) combined with chemotherapy in locally advanced pancreatic cancer: protocol of a single-centre, phase II clinical trial. BMJ Open. 2022 Aug 29;12(8):e049382. doi: 10.1136/bmjopen-2021-049382. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | SBRT of BED<70Gy combined with Gemcitabine + albumin-bound paclitaxel |
| FG001 | Arm B | SBRT of BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | SBRT of BED<70Gy combined with Gemcitabine + albumin-bound paclitaxel |
| BG001 | Arm B | SBRT of BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free-Survival | Progression-Free-Survival | Posted | Median | 95% Confidence Interval | month | 3 years |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | SBRT of BED<70Gy combined with Gemcitabine + albumin-bound paclitaxel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaofei Zhu | Changhai Hospital | 86-021-31162222 | zhuxiaofei_zxf@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2020 | Sep 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Chemotherapy |
| Drug |
Gemcitabine 1000mg/m^2 and nab-paclitaxel 125mg/m^2, administered intravenously, on day 1 and 8 of a 21-day cycle for six cycles |
|
| Shanghai |
| Shanghai Municipality |
| 200433 |
| China |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Baseline characteristics | Count of Participants | Participants |
|
|
|
| Secondary | Adverse Events | Adverse events | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Overall Survival | Overall Survival | Posted | Median | 95% Confidence Interval | months | 3 years |
|
|
|
| 60 |
| 60 |
| 26 |
| 60 |
| 58 |
| 60 |
| EG001 | Arm B | SBRT of BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel | 55 | 59 | 25 | 59 | 57 | 59 |
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Nausea or vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Elevated aspartate aminotransferase | Hepatobiliary disorders | Non-systematic Assessment |
|
| Elevated alanine aminotransferase | Hepatobiliary disorders | Non-systematic Assessment |
|
| Peripheral neurotoxicity | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Blood bilirubin increased | Hepatobiliary disorders | Non-systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Weight decreased | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Nausea or vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Elevated aspartate aminotransferase | Hepatobiliary disorders | Non-systematic Assessment |
|
| Elevated alanine aminotransferase | Hepatobiliary disorders | Non-systematic Assessment |
|
| Peripheral neurotoxicity | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Blood bilirubin increased | Hepatobiliary disorders | Non-systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Weight decreased | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Alopecia | General disorders | Non-systematic Assessment |
|
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