NCT03492671 Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer
| NCT ID | NCT03492671 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Loma Linda University |
| Condition | Pancreas Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-07-17 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2019-07-17 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Naveenraj Solomon, MD
PRINCIPAL INVESTIGATOR
Loma Linda University Cancer Center
Frequently Asked Questions
Who can join the NCT03492671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03492671 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03492671 currently recruiting?
Yes, NCT03492671 is actively recruiting participants. Contact the research team at nsolomon@llu.edu for enrollment information.
Where is the NCT03492671 trial being conducted?
This trial is being conducted at Loma Linda, United States.
Who is sponsoring the NCT03492671 clinical trial?
NCT03492671 is sponsored by Loma Linda University. The principal investigator is Naveenraj Solomon, MD at Loma Linda University Cancer Center. The trial plans to enroll 30 participants.