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2016-09-16
2027-12
2027-12
46
NCT03073785
University of Nebraska
University of Nebraska
INTERVENTIONAL
Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates. This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, 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. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates. This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, 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. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer. The primary study objective is to evaluate the efficacy of hypofractionated radiation therapy concurrently with zoledronic acid (Zometa) and fluorouracil or capecitabine. Other study objectives include examining the toxicity of Zometa when used concurrently with hypofractionated radiation therapy, evaluating local failure-free survival and overall survival, determining surgical resection and tumor response rates, measuring Zometa pharmacokinetics, evaluating tumor and organ motion and determining the effect those on the dosimetry, local control and survival. Post-treatment follow-up is for 30 days, then every 3 months for the first year, every 4 months for the second year, and every 6 months thereafter.
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 |
|---|---|---|
2017-02-28 | N/A | 2025-05-20 |
2017-03-02 | N/A | 2025-05-25 |
2017-03-08 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Arm A (chemotherapy, radiation therapy) Participants undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5. Participants receive fluorouracil IV over 24 hours on day 1 weekly for 4 weeks or capecitabine by mouth every 12 hours starting the evening before day 1 | DRUG: Capecitabine
DRUG: Fluorouracil
OTHER: Laboratory Biomarker Analysis
OTHER: Pharmacological Study
RADIATION: Stereotactic Body Radiation Therapy
|
| EXPERIMENTAL: Arm B (zoledronic acid, chemotherapy, radiation therapy) Participants receive zoledronic acid IV over a minimum of 15 minutes 1 week prior to radiation therapy. Participants undergo hypofractionated stereotactic body radiation therapy and receive treatment with fluorouracil IV or capecitabine by mouth as in Arm | DRUG: Capecitabine
DRUG: Fluorouracil
OTHER: Laboratory Biomarker Analysis
OTHER: Pharmacological Study
RADIATION: Stereotactic Body Radiation Therapy
DRUG: Zoledronic Acid
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Local control With and Without Zometa at Four Months in Follow-up | Local control of tumor will be determined by four dimensional (4D) computed tomography (CT) scans and comparison made between participants receiving Zometa and those who don't. | At 4 months in follow-up |
| Local control With and Without Zometa at Eight Months in Follow-up | Local control of tumor will be determined by four dimensional (4D) computed tomography (CT) scans and comparison made between participants receiving Zometa and those who don't. | At 8 months in follow-up |
| Local control With and Without Zometa at Twelve Months in Follow-up | Local control of tumor will be determined by four dimensional (4D) computed tomography (CT) scans and comparison made between participants receiving Zometa and those who don't. | At 12 months in follow-up |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Zoledronic Acid | Maximum tolerated dose of zoledronic acid will be determined by dose limiting toxicities according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Safety variables to be analyzed are adverse events (AE) and serious adverse events (SAE). AEs and SAEs will be tallied for overall frequency (number and percentage of subjects), worst reported severity, and relationship to study drugs. | Up to 30 days after surgery |
| Local Failure-free Survival With and Without Zometa | Time to local failure (disease progression or recurrence determined by imaging, or death) will be analyzed using Kaplan-Meier method between participants receiving Zometa and those who don't. | From date of administration of study drug to the date of local failure, assessed up to 5 years |
| Overall Survival With and Without Zometa | Time to death will be analyzed using Kaplan-Meier method between participants receiving Zometa and those who don't. | From date of administration of study drug to the date of death, assessed up to 5 years |
| Surgically Complete Resection Rate With and Without Zometa | The number and proportion of participants undergoing complete resection (negative margin) will be determined between participants receiving Zometa and those who don't. | Immediately after surgery |
| Pathologic Response After Resection With and Without Zometa | The pathologic response will be scored from 0-9 by a pathologist, 0 is no response and 9 is complete response between participants receiving Zometa and those who don't. | Immediately after surgery |
| Change in Tumor Size after Stereotactic Body Radiation Therapy With and Without Zometa | Tumor size will be measured on computed tomography (CT)/magnetic resonance imaging (MRI) before and after stereotactic body radiation therapy (SBRT) and compared between participants receiving Zometa and those who don't. | Within 1 month prior to SBRT and 4-5 weeks after SBRT |
| Change of maximum and average Standardized Uptake Values after Stereotactic Body Radiation Therapy With and Without Zometa | The maximum and average standardized uptake values SUV will be measured on Positron Emission Tomography (PET) before and after Stereotactic Body Radiation Therapy (SBRT) and will be compared between participants receiving Zometa and those who don't. | Within 1 month prior to SBRT and 4-5 weeks after SBRT |
| Tumor and Organ Motion | The amplitude of 3D tumor/organ motion will be measured using four dimensional (4D) computed tomography (CT) scans. | Immediately prior to stereotactic body radiation therapy (SBRT) |
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:
19 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
