Clinical trial · Interventional
Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Patients With Borderline Resectable Pancreatic Cancer
Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Borderline Resectable Pancreatic Cancer : Phase II Study
NCT03199144CI-TRIAL-00059266CKPancreaswithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulties to recruit patients
Summary
Brief summary (as posted)
The goal of the present study is to test if in situations of borderline resectable patients a neoadjuvant treatment combining Gemzar-Abraxane and stereotactic radiosurgery could increase the median OS rates above 30 months that means at least 12 months more than the 18-20 months generally described.
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 Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Stereotactic radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic radiotherapy
- description
- Stereotactic radiotherapy delivering 30 Gy in 5 fractions over 9 days
- interventionNames
- Drug: Chemotherapy
- Radiation: Stereotactic radiotherapy
- Procedure: Surgery
Primary outcomes (1)
- measure
- patient overall survival
- timeFrame
- follow up during 3 years after patient inclusion
- description
- patient overall survival
Secondary outcomes (4)
- measure
- positive surgical margins
- timeFrame
- follow up during 3 years after patient inclusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven pancreatic adenocarcinoma * Borderline resectable pancreatic adenocarcinoma (NCCN guidelines) * OMS status ≤2 * Age at presentation \>18 y * Absolute neutrophil counts \>1500/ml * Absolute platelet count \>100000/ml * GOT and GPT \<2.5 x the upper limit of normal * Total bilirubin \< the upper limit of normal * Serum creatinin \< upper limit of normal * Coagulation test within limit of normal (Prothrombin time, INR) +/- 15% * No evidence of jaundice at enrolment. If stent required to alleviate jaundice it should be metallic * Patient must be able to eat without a feeding tube and can take medications orally * Disease must be encompassed in a reasonable radiation field * Signed informed consent Exclusion Criteria: * Distant metastases * Evolutive disease after the neoadjuvant chemotherapy course according RECIST criteria * Neuroendocrine tumors * Peritoneal dissemination visualized at diagnostic abdominal CT scan * Pathologic abdominal nodes visualized at diagnostic abdominal CT scan outside the pancreatic area * Pathologic PET scan outside the pancreatic area * Inoperability for medical reasons * Inability to tolerate chemotherapy for medical (in particular grade II or more neuropathy) or allergic purposes, or for OMS score \>2 * Inability to tolerate Whipple resection * Collagenose diseases * Cancer evolution outside the pancreatic bed at the PET scanner performed just after the 3 neo adjuvant chemotherapy cycles * Any previous cancer in the 5 years excepted a basal skin cell carcinoma or in situ cervical cancer * Active infection with HIV, Hepatitis B or c * Pregnant patient
References
Publications (0)
Data not yet available
No reference posted for this study.