Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT
Condition: Lung Neoplasm
MeSH terms: Lung Neoplasms
Intervention: risedronate; Matching placebo
Intervention description: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT; Dose not applicable, given once 7-21 days prior to initiation of SBRT
Intervention MeSH terms: Risedronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is
      that the use of a single dose of 150 mg risedronate will eliminate or greatly reduce the
      rapid bone loss that occurs with radiation induced early osteoclast recruitment/activation.

      Patients will be given either a single dose of 150 mg risedronate or placebo at the time of
      their treatment mapping "simulation" CT scan. Typically, radiation treatments begin at 1 - 3
      weeks following this mapping scan, as each treatment plan requires detailed physics
      calculations and quality assurance checks.

      All CT imaging referenced below is performed as a routine standard of care surveillance and
      is necessary for cancer treatment follow-up. These chest CT scans that are utilized in this
      research protocol would be performed every 3 months regardless of inclusion on this trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

        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.