Clinical trial · Interventional
Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses
A Prospective Phase Ⅱ Clinical Study of Stereotactic Radiotherapy Combined With Chemotherapy With Different Biological Effective Doses (<70gy vs. >70Gy) in Locally Advanced Pancreatic Cancer
NCT04603586CI-TRIAL-00096662completedN/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 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.
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
- SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel
- interventionNames
- Radiation: SBRT
- Drug: Chemotherapy
- type
- EXPERIMENTAL
- label
- Arm B
- description
- SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel
- interventionNames
- Radiation: SBRT
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Progression-Free-Survival
- 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, 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 (1)
- DERIVEDYe 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. PMID 36038164