Combining chemotherapy and radiation before surgery for 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
This study is testing if giving chemotherapy and radiation before surgery can help people with localized pancreatic cancer have better chances of completely removing the cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT03492671 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial aims to evaluate the effectiveness of a combination of two FDA-approved chemotherapy drugs, gemcitabine and nab-paclitaxel, along with radiation therapy, administered prior to surgery in patients with localized pancreatic cancer. The primary goal is to achieve an R0 resection rate of 70% or higher, indicating complete removal of cancerous tissue. Participants will receive up to four cycles of chemotherapy followed by surgery, with additional chemotherapy post-surgery. The study will also assess secondary outcomes such as disease-free survival and overall survival rates.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with localized, potentially resectable pancreatic adenocarcinoma and good overall health.
Not a fit: Patients with borderline resectable or metastatic pancreatic cancer, or those with a history of other malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and survival rates for patients with localized pancreatic cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and radiation in treating pancreatic cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Loma Linda, California
- Loma Linda University Health — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Naveenraj Solomon, MD — Loma Linda University Cancer Center
- Study coordinator: Naveenraj Solomon, MD
- Email: nsolomon@llu.edu
- Phone: 909-558-5498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.