Clinical trial · Interventional
Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer
Phase II Trial Evaluating Stereotactic Body Radiation Therapy (SBRT) After Induction Chemotherapy for Patients With Locally Advanced Unresectable Pancreatic Cancer
NCT03158779CI-TRIAL-00060868completedPhase 2ClinicalTrials.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 phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with unresectable pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT and chemotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT and chemotherapy
- description
- Participants received 4 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. A 3-weeks break from chemotherapy and restaging with thorax-abdominal CT scan to confirm the absence of distant metastases was required before SBRT delivery. Before SBRT simulation, patients may will have implanted fiducial into the pancreatic tumor. The SBRT schedule will be \[6 x 9 Gy = 54 Gy\] delivered in consecutive days.
- interventionNames
- Combination Product: SBRT and chemotherapy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 2 years
- description
- Evaluation of SBRT after induction CT with FOLFIRINOX or Gemcitabine-Abraxane in terms of overall survival time that will be calculated from the start of chemotherapy to death.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically and/or radiologically (CT scan and/or MRI scan and/or FDG-PET) proven unresectable locally advanced pancreatic cancer, discussed multidisciplinary by tumor board. * Eighteen years of age or older, * Minimum Karnofsky Performance Status of 70. * Lesions cannot exceed 5 cm in maximum diameter. * Absence of lymph-nodal metastases * Patients received 4-6 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. * Baseline total body CT scan performed no more than 2 months before treatment. * Placing fiducial markers through endoscopes is permitted (EUS-guided fiducials placement before the treatment). * Acceptable organ and bone marrow function. * Ability to maintain the set-up position during RT. * All patients give informed consent and sign a study-specific informed consent form. Exclusion Criteria: * Metastatic disease * Prior abdominal radiotherapy * Other malignancies diagnosed within 5 years * Gastric or duodenal obstruction. * Concurrent chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.