Treatment
Conditions
Keywords
SBRT, Locally Advanced Pancreatic Cancer, Biological Effective Dose
Brief summary
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.
Interventions
RADIATIONSBRT
SBRT: in 5-6 fractions with CyberKnife
DRUGChemotherapy
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
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cytologically or histologically verified pancreatic adenocarcinoma * Imaging examinations confirmed locally advanced pancreatic cancer * No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy * ECOG of 0 to1 * Age of 18 years or older * Adequate bone marrow function, defined as: Absolute neutrophil count (ANC) ≥ 1.5×10\^9 cells/L, leukocyte count≥ 3.5×10\^9 cells/L, platelets ≥ 70×10\^9 cells/L, hemoglobin ≥ 8.0 g/dl * Adequate liver and renal, defined as: Albumin \> 2.5 g/dL, total bilirubin \< 3 mg/dL, creatinine \< 2.0 mg/dL, AST\<2.5 × ULN (Upper Limit of Normal) (0-64U/L), ALT\<2.5 × ULN (0-64U/L) * Adequate blood clotting function, defined as: international normalized ratio (INR) \< 2 (0.9-1.1) * Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Previously receiving radiotherapy, immunotherapy or targeted therapy * Evidences of metastatic disease confirmed by chest CT or PET-CT * ECOG ≥2 * Age \<18 years * Secondary malignancy * Abnormal results of blood routine examinations and liver and kidney and coagulation tests * Patients with active inflammatory bowel diseases or peptic ulcer * Gastrointestinal bleeding or perforation within 6 months * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * Medical history of symptomatic congestive heart failure: New York Heart Association Class III to IV * Medical history of respiratory insufficiency * Women who are pregnant or breastfeeding * Participation in another clinical treatment trial * Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival | 3 years | Progression-Free-Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 3 years | Adverse events |
| Overall Survival | 3 years | Overall Survival |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel | 60 |
| Arm B SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel | 59 |
| Total | 119 |
Baseline characteristics
| Characteristic | Arm A | Arm B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 32 Participants | 65 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 27 Participants | 54 Participants |
| Baseline characteristics | 60 Participants | 59 Participants | 119 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 28 Participants | 55 Participants |
| Sex: Female, Male Male | 33 Participants | 31 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 60 / 60 | 55 / 59 |
| other Total, other adverse events | 58 / 60 | 57 / 59 |
| serious Total, serious adverse events | 26 / 60 | 25 / 59 |
Outcome results
Primary
Progression-Free-Survival
Progression-Free-Survival
Time frame: 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A | Progression-Free-Survival | 8.6 month |
| Arm B | Progression-Free-Survival | 11.3 month |
Secondary
Adverse Events
Adverse events
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | Adverse Events | 58 Participants |
| Arm B | Adverse Events | 57 Participants |
Secondary
Overall Survival
Overall Survival
Time frame: 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A | Overall Survival | 12.2 months |
| Arm B | Overall Survival | 17.2 months |