Clinical trial · Interventional
Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer
A Phase II Trial of Pre-operative Chemotherapy (With Gemcitabine and Nab- Paclitaxel) and Stereotactic Body Radiotherapy Followed by Surgery and Chemotherapy in Patients With Resectable Pancreatic Adenocarcinoma
- 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 phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Adenocarcinoma | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Resectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine 1000 mg | Drug | Gemcitabine | ALIAS |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy and SBRT
- description
- Pre-Operative Chemotherapy: Within 28 days of study enrollment, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of four 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15. Post-Operative Chemotherapy: Within 5-10 weeks after surgery, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of two 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15. Standard Stereotactic Body Radiation Therapy (SBRT) fractionation of 6 Gy per day will be used for all patients to a total dose of 30 Gy.
- interventionNames
- Drug: Gemcitabine 1000 mg
- Drug: nab-paclitaxel
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
- measure
- Curative Intent Resection (R0) rate
- timeFrame
- Within 2 weeks prior to initiation of post-operative chemotherapy.
- description
- Measure the rate of R0 resection with all margins microscopically clear.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (all criteria must apply): * Cytologic or histologic proof of adenocarcinoma of the pancreas. * Localized, potentially resectable tumors. * Greater or equal to 18 years of age. * ECOG performance status of 0 or 1. * Adequate hematologic, renal and hepatic function as defined by: * ANC greater or equal to 1,500 cells/mm3 * Platelets greater or equal to 100,000 cells/mm3 * Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) * Serum creatinine ≤ 2 x ULN • ALT ≤ 5 x ULN * AST ≤ 5 x ULN * No history of prior therapy for pancreatic cancer. * No history of active infection requiring IV antibiotics at the start of study treatment * Non-pregnant and non-breast-feeding. Exclusion Criteria: * Patient has borderline resectable or metastatic disease. * History of malignancy in the last 5 years other than in situ cancer or basal or squamous cell skin cancer or malignancies cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years. * Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
References
Publications (0)
Data not yet available