Clinical trial · Interventional
Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer
Recurrence-pattern-based Volume Versus Conventional-volume Stereotactic Body Radiation Therapy in Locally Advanced Pancreatic Cancer: an Open-label, Randomized, Phase 2 Trial
NCT04699539CI-TRIAL-00098746completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Treatment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- A conventional-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel
- interventionNames
- Radiation: SBRT
- Drug: Chemotherapy
- type
- EXPERIMENTAL
- label
- Arm B
- description
- A recurrence-pattern-based-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel
- interventionNames
- Radiation: SBRT
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- 1-year Progression Free Survival Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.