NCT03492671RecruitingPhase 2
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 · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Apr 2018
- Start date
- 17 Jul 2019
- Primary completion date
- Sept 2026
- Lead sponsor
- Loma Linda University
- Diseases
- Pancreatic cancer
- NCT number
- NCT03492671
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 17 Jul 2019 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Loma Linda University Health Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.