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The purpose of this study is to compare the efficacy and safety of a recurrence-pattern-based-volume versus conventional-volume stereotactic body radiation therapy for locally advanced pancreatic cancer, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | A conventional-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel |
|
| Arm B | Experimental | A recurrence-pattern-based-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | A conventional-volume stereotactic body radiation therapy: planning target volume should include gross tumor volume with a uniform 3mm margin in all directions. A recurrence-pattern-based volume stereotactic body radiation therapy: planning target volume should include gross tumor volume with a 3mm margin in the anterior and lateral directions, 10mm margin in the cranial and caudal directions that should cover the full circumstance of celiac artery and superior mesenteric artery, 15mm in the posterior direction that should cover the retroperitoneal space. The prescribed dose of PTV varies from 30-50Gy/5-6f. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Progression Free Survival Rate | The proportion of patients without disease progression at one year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Adverse Events | Treatment-related adverse events | 4 years |
| Progression Free Survival | Progression free survival | 4 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | A conventional-volume SBRT following gemcitabine and nab-paclitaxel |
| FG001 | Arm B | A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | A conventional-volume SBRT following gemcitabine and nab-paclitaxel |
| BG001 | Arm B | A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 1-year Progression Free Survival Rate | The proportion of patients without disease progression at one year | Posted | Count of Participants | Participants | 1 year |
|
|
4 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 | A conventional-volume SBRT following gemcitabine and nab-paclitaxel | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaofei Zhu | Changhai Hos | 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 16, 2020 | Oct 1, 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/m2,d1, 8) + albumin-bound paclitaxel (125mg/m2,d1, 8) , repeat every 3 weeks for 6 cycles |
|
| Overall Survival | Overall Survival | 4 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| Age, Continuous | Median | Inter-Quartile Range | yerars |
|
| 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 |
|
| Participants | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Treatment-related Adverse Events | Treatment-related adverse events | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Progression Free Survival | Progression free survival | Posted | Median | 95% Confidence Interval | months | 4 years |
|
|
|
| Secondary | Overall Survival | Overall Survival | Posted | Median | Inter-Quartile Range | months | 4 years |
|
|
|
| 47 |
| 20 |
| 47 |
| 43 |
| 47 |
| EG001 | Arm B | A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel | 49 | 49 | 21 | 49 | 42 | 49 |
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Nausea or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated aspartate aminotransferase | Hepatobiliary disorders | Systematic Assessment |
|
| Elevated alanine aminotransferase | Hepatobiliary disorders | Systematic Assessment |
|
| Hypoalbuminemia | Hepatobiliary disorders | Systematic Assessment |
|
| Weight decreased | Metabolism and nutrition disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Nausea or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated aspartate aminotransferase | Hepatobiliary disorders | Systematic Assessment |
|
| Elevated alanine aminotransferase | Hepatobiliary disorders | Systematic Assessment |
|
| Blood bilirubin increased | Hepatobiliary disorders | Systematic Assessment |
|
| Hypoalbuminemia | Hepatobiliary disorders | Systematic Assessment |
|
| Weight decreased | Metabolism and nutrition disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Peripheral neurotoxicity | Nervous system disorders | Systematic Assessment |
|
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