Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoma Linda University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Gemcitabine 1000 mg
- nab-paclitaxel
- Stereotactic Body Radiation Therapy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov