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2016-01-21
2019-11-12
2022-12-12
20
NCT02427841
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
INTERVENTIONAL
Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride followed by radiation therapy before surgery work in treating patients with pancreatic cancer that can be removed by surgery. Chemotherapy drugs, such as nab-paclitaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel, gemcitabine hydrochloride, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVE: I. To determine the R0 (complete resection) resection rate for subjects with borderline resectable or lymph node positive pancreatic adenocarcinoma treated with a multimodality neoadjuvant therapy of preoperative gemcitabine (gemcitabine hydrochloride) and ABRAXANE (nab-paclitaxel) followed by 5-fluorouracil (fluorouracil) based image-guided intensity-modulated radiation therapy (IG-IMRT) chemoradiotherapy. SECONDARY OBJECTIVES: I. To determine 1-year relapse-free survival rate with the investigational protocol. II. To determine 1-year and 2-year overall survival rates. III. To assess response rate by imaging (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and pathologic analysis. IV. To assess the toxicity and safety according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) criteria. OUTLINE: PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel intravenously (IV) over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for 1 year.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-04-17 | 2020-10-26 | 2023-08-14 |
2015-04-22 | 2021-01-11 | 2023-09-06 |
2015-04-28 | 2021-01-14 | 2023-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Treatment (chemotherapy, chemoradiation therapy, surgery) PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxic | DRUG: Fluorouracil
DRUG: Gemcitabine
RADIATION: Image Guided Radiation Therapy
RADIATION: Intensity-Modulated Radiation Therapy
OTHER: Laboratory Biomarker Analysis
DRUG: Nab-paclitaxel
PROCEDURE: Therapeutic Conventional Surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment | The R0 resection rate, measured as the percent of participants achieving R0 resection among those who initiate study drug, will be computed with 95% confidence interval. A 2-sided binomial test will be used to determine whether the R0 resection rate is significantly greater than 0.37 at 10% significance level. | At the time of surgery |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Frequency and severity of adverse events will be tabulated based on the actual treatment and the number of courses the patient receives. In particular, grade 3 and 4 toxicity rates will be computed and summarized for all patients received at least one dose of the assigned treatment. | From the first dose of study drug(s) until 28 days after last study intervention, up to approximately 3 years, 10 months |
| Overall Survival Rate Defined as the Percentage of Subjects Alive at the 2 Year Time Point | The expected 2-year overall survival rate (%) will be reported with an associated 95% confidence interval for all enrolled participants (n = 19). Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to two years. Participants known still alive at two-years will be censored at two years. Any participant lost to follow up during the two-year period will be censored on the last date known alive. | From first dose of study drug until 2 years or time of death by any cause, which ever comes first. Participants are assessed every 3 months after completing study interventions. |
| Overall Survival Rate Defined as the Percentage of Subjects Alive at the One Year Time Point | The expected 1-year overall survival rate (%) will be reported with an associated 95% confidence interval. Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to one year. Participants known still alive at one-year will be censored at one year. Any participant lost to follow up during the one-year period will be censored on the last date known alive. | From first dose of study drug until 1 year or time of death by any cause, whichever comes first. Participants are assessed every 3 months after completing study interventions. |
| Relapse-free Survival Rate Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor | The expected 1-year relapse-free survival rate (%) will be reported with an associated 95% confidence interval for those who undergo resection (n = 11). Resection-free survival is assessed from the time of resection until time of progression or death by any cause, up to one year. Participants known still alive and without progression at one-year post-resection will be censored at one year. Any participant lost to follow up during the one-year post-resection period will be censored on the last disease assessment date. Response is measured per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymph nodes are assessed. Progression is at least 20% increase in sum of diameters of target lesions (referencing nadir sum of diameters) and an absolute increase of at least 5 mm. Presence of any new lesion is also considered progression disease. | From time of resection until progression or death by any cause, within 1 year of resection. Participants are assessed by imaging every 3 months after completing study interventions. |
| Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Percent of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT) | The objective response rate (percentage of participants having complete response (CR) or partial response (PR)) will be computed with associated 95% confidence interval using the binomial exact method. Response is measured per RECIST 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymphnodes are assessed. CR is the disappearance of all target lesions; any pathologic lymph nodes must show a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions using the baseline sum of diameters of target lesions as the reference level. | From first dose of study drug(s), with assessments at Staging 1 (approximately 2 months) and Staging 2 (approximately 5 months after first dose of study drug(s)). |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
