This phase II trial studies neoadjuvant therapy (treatment given as a first step to shrink a tumor before the main treatment) comprising gemcitabine hydrochloride, nab-paclitaxel, and hypofractionated, image-guided, intensity modulated radiation therapy (HIGRT) before surgery in treating patients with newly diagnosed pancreatic cancer that can potentially be removed by surgery. Giving gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, and HIGRT before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. HIGRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving neoadjuvant gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation together with HIGRT may be a better treatment for pancreatic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02318095.
PRIMARY OBJECTIVES:
I. To determine if neoadjuvant gemcitabine hydrochloride (gemcitabine)/nab-paclitaxel and HIGRT is feasible in patients with potentially resectable pancreatic cancer.
SECONDARY OBJECTIVES:
I. To evaluate grade >= 2 acute toxicity.
II. To assess resection rate.
III. To assess complete surgical resection (R0) resection rate.
TERTIARY OBJECTIVES:
I. To assess perioperative surgical complication rates (i.e. wound complications/infections, delayed gastric emptying, pancreatic leak, estimate blood loss, operative times).
II. To assess for late toxicity with this neoadjuvant regimen.
III. To evaluate local control and rate of distant metastasis with this neoadjuvant regimen.
IV. To evaluate median progression free survival (PFS).
V. To evaluate median overall survival (OS) with this neoadjuvant regimen.
VI. To evaluate pathologic complete response (pCR) and percentage of viable tumor, percent fibrosis and histologic grading of treatment response in surgical specimens with this neoadjuvant regimen compared to historical control rates with chemoradiation (CRT) alone and neoadjuvant stereotactic body radiation therapy (SBRT).
VII. To evaluate radiographic response after receipt of neoadjuvant gemcitabine/nab-paclitaxel and HIGRT in the neoadjuvant setting.
VIII. To explore the effects of this neoadjuvant regimen on markers of tumor perfusion and hypoxia.
OUTLINE:
Patients receive standard of care neoadjuvant chemotherapy comprising gemcitabine hydrochloride and nab-paclitaxel at the discretion of the treating physician on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo 5 fractions of HIGRT over 5-10 days. At the discretion of the treating physician, patients may then undergo scheduled surgery.
After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually for 3 years.
Lead OrganizationDuke University Medical Center
Principal InvestigatorManisha Palta
