Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT

NCT03861091 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: IRB00056835CCCWFU99518P30CA012197
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Lung Neoplasm

Outcome Measures

Primary Outcomes (1)

• Changes in Mean Cortical Thickness

  The primary outcome measure is the percent change in mean cortical thickness (C.Th) of bones receiving 30 Gy or more at 3 months post SBRT, when compared to pre-SBRT cortical thickness

  At baseline and at 3 months post radiation

Secondary Outcomes (4)

• 4 Time Points Assessing Change in Mean Cortical Thickness of Bones

  At baseline, 3 months, 6 months, 9 months and 12 months post radiation

• Number of Participants With Chest Wall Pain

  At baseline, 3 months, 6 months, 9 months and 12 months post radiation

• Number of Participants With Rib and Vertebral Fracture

  At 12 months post radiation

• Urine Concentration at 4 Time Points

  At 3 months, 6 months, 9 months and 12 months post radiation

Study Arms (2)

Risedronate

EXPERIMENTAL

Risedronate 150 mg given once 7-21 days prior to initiation of SBRT

Drug: risedronate

Matching Placebo

PLACEBO COMPARATOR

Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT

Drug: Matching placebo

Interventions

risedronate DRUG

Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT

Also known as: Actonel, Atelvia

Risedronate

Matching placebo DRUG

Dose not applicable, given once 7-21 days prior to initiation of SBRT

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

High Point Regional Medical Center

High Point, North Carolina, 27262, United States

Location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Biostatistician
• Organization: Wake Forest Baptist Comprehensive Cancer Center

blevine@wakehealth.edu

336-716-5440

Study Officials

• Michael Farris, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: July 12, 2019
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: July 27, 2023
• Results First Posted: July 14, 2023

Record last verified: 2023-07

Locations

US (2)