Status:
COMPLETED
Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for periph...
Detailed Description
2.1 Primary Objective(s) The primary objective is to assess the percent change in bone mean cortical thickness within regions of bone receiving 30 Gy or more at 3 months after SBRT. The % change in m...
Eligibility Criteria
Inclusion
- Patients must be 18 years or older, but there is no upper limit on age of inclusion.
- Patients must have a peripheral lung tumor that is amenable to SBRT as determined by the treating radiation oncologist. To be classified as a peripheral lung tumor, the tumor edge (the edge of the gross tumor volume or GTV in radiation treatment planning software) must be within 2 cm of the chest wall. This is determined by the treating radiation oncologist. The chest wall is defined as the chest wall musculature or ribs/vertebrae immediately adjacent to the lungs.
- Patients must have ECOG status of 0-3
- Patients must have a life expectancy of at least 3 months as determined by the treating radiation oncologist.
- Patients must have the ability to understand and the willingness to sign an IRB-approved informed consent document.
Exclusion
- Prior radiation to any part of the body including the lungs or thorax is not an exclusion criteria
- Tumor edge is greater than 2 cm from the chest wall. The edge of tumor is the edge of the gross tumor volume or GTV as defined in radiation treatment planning software. This is determined by the treating radiation oncologist.
- Tumors that are expected to require more than 10 fractions of radiation as determined by the treating radiation oncologist.
- History of using bone anti-resorptive agents including bisphosphonates or RANK-L inhibitors within the last 1 year.
- Inability to stand or sit upright for at least 30 minutes, which is necessary for ingestion of risedronate.
- Hypocalcemia defined as serum total calcium lower than 8.5 mg/dL on most recent bloodwork that is within 3 months of administration of study drug/placebo.
- Severe renal impairment (EGFR \<30 mL/min) on most recent bloodwork that is within 3 months of administration of study drug/placebo.
- Known allergy to risedronate or other bisphosphonates
- Surgery affecting the bone or dental operations within the last 6 months. This will be explicitly asked and documented in the EMR by treating radiation oncologist.
- Dental operations do not include routine cleaning or cavity fillings
- Dental operations that exclude patients refer to any manipulation of mandible.
- Positive urine pregnancy test in women of child bearing potential within 1 week of registration. Pregnant women are excluded from this study because radiation has clear teratogenic and potentially abortifacient risks.
Key Trial Info
Start Date :
July 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2022
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03861091
Start Date
July 12 2019
End Date
March 2 2022
Last Update
July 27 2023
Active Locations (2)
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1
High Point Regional Medical Center
High Point, North Carolina, United States, 27262
2
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157