Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02318095|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Resectable Pancreatic Cancers||Drug: Gemcitabine/nab-Paclitaxel Radiation: Radiation therapy Other: Sugical resection Drug: Adjuvant chemotheapy||Not Applicable|
Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and accounts for roughly 40,000 deaths each year. Despite the use of neoadjuvant and adjuvant therapies, little progress has been made in the the last three decades, and the search for more efficacious treatment continues.In patients with a good performance status the combination of effective systemic therapy with gemcitabine/nab-paclitaxel and high dose local radiotherapy may improve disease outcomes. This is a prospective, single arm study in patients in newly diagnosed, previously untreated pancreatic cancer who are planned to undergo surgical resection The primary objective of this study is to evaluate the toxicity of a neoadjuvant approach incorporating gemcitabine/nab-paclitaxel and Hypofractionated image guided intensity-modulated radiotherapy (HIGRT) prior to surgical resection. Eligible subjects will recieve standard neoadjuvant gemcitabine and nab-paclitaxel dosing is as follows:Nab-Paclitaxel (125mg/m2) days 1,8,15 every 28 days for 2 cycles Gemcitabine (1000mg/m2) days 1,8,15 every 28 days for 2 cycles followed by HIGRT and surgical resection.
Adjuvant chemotherapy may be given post surgery at the discretion of the treating medical oncologist.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Neoadjuvant Gemcitabine/Nab-Paclitaxel and Hypofractionated Image-Guided Intensity Modulated Radiotherapy in Resectable and Borderline Resectable Pancreatic Cancer|
|Actual Study Start Date :||February 17, 2015|
|Actual Primary Completion Date :||November 7, 2018|
|Estimated Study Completion Date :||January 2020|
This is a single arm prospective study. All eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist.
Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy.
Radiation: Radiation therapy
5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.
Other: Sugical resection
Surgical resection of the pancreas post radiation therapy
Drug: Adjuvant chemotheapy
Adjuvant chemotherapy may be given after surgery at the clinical discretion of the medical oncologist
- Feasibility of neoadjuvant gemcitabine/nab-paclitaxel and HIGRT in patients with potentially resectable pancreatic cancer. [ Time Frame: 3 years ]The neoadjuvant regimen will be considered feasible if (a) the trial can accrue 25 patients in no more than 3 years and (b) if at least 18 of the 25 patients adhere to the neoadjuvant regimen.
- Grade >/=2 acute toxicity [ Time Frame: Baseline to 60 days post surgery ]CTCAE version 4 will be used for all toxicity assessments. The acute toxicity rate, defined as any non-hematologic grade 2+ toxicity occurring during treatment through 60 days post-treatment, will be estimated with its exact 80% confidence interval. Likewise, we will determine the rate of grade 2+ hematologic toxicity occurring during treatment through 60 days post treatment and the proportion of patients requiring treatment breaks longer than 5 days.
- Resection rate [ Time Frame: Post surgery ]Patients who undergo surgical resection will be documented
- R0 resection rate [ Time Frame: 14-30 days post surgery ]Pathologic review will determine if an R0 resection has been performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318095
|United States, North Carolina|
|Duke Cancer Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Manisha Palta, MD||Duke University Health System|