Treatment
Conditions
Keywords
SBRT, Locally Advanced Pancreatic Cancer, Target Delineation
Brief summary
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.
Interventions
RADIATIONSBRT
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.
DRUGChemotherapy
Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8) , repeat every 3 weeks for 6 cycles
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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, chemotherapy, 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 |
|---|---|---|
| 1-year Progression Free Survival Rate | 1 year | The proportion of patients without disease progression at one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related Adverse Events | 4 years | Treatment-related adverse events |
| Progression Free Survival | 4 years | Progression free survival |
| Overall Survival | 4 years | Overall Survival |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A A conventional-volume SBRT following gemcitabine and nab-paclitaxel | 47 |
| Arm B A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel | 49 |
| Total | 96 |
Baseline characteristics
| Characteristic | Arm A | Arm B | Total |
|---|---|---|---|
| Age, Continuous | 66 yerars | 63 yerars | 63.5 yerars |
| Participants | 47 Participants | 49 Participants | 96 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 26 Participants | 29 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 47 / 47 | 49 / 49 |
| other Total, other adverse events | 43 / 47 | 42 / 49 |
| serious Total, serious adverse events | 20 / 47 | 21 / 49 |
Outcome results
Primary
1-year Progression Free Survival Rate
The proportion of patients without disease progression at one year
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | 1-year Progression Free Survival Rate | 9 Participants |
| Arm B | 1-year Progression Free Survival Rate | 18 Participants |
Secondary
Overall Survival
Overall Survival
Time frame: 4 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A | Overall Survival | 10.8 months |
| Arm B | Overall Survival | 15.2 months |
Secondary
Progression Free Survival
Progression free survival
Time frame: 4 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A | Progression Free Survival | 7.3 months |
| Arm B | Progression Free Survival | 9.6 months |
Secondary
Treatment-related Adverse Events
Treatment-related adverse events
Time frame: 4 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | Treatment-related Adverse Events | 45 Participants |
| Arm B | Treatment-related Adverse Events | 46 Participants |