CSU Animal Cancer Center Clinical Trial

Patient Disease:
Osteosarcoma

Study Name:
Radiation therapy with or without bisphosphonates for palliative treatment or canine osteosarcoma.

Purpose of the study:
This study is designed to evaluate whether the addition of pamidronate (a drug that inhibits bone loss) to the current standard of care palliative treatment (radiation therapy and pain killer medications) improves quality of life and limb function outcomes for dogs affected by bone cancer of the limbs. Patients in the study will be assigned to one of two groups; one that is treated with bisphosphonates plus standard palliative treatment and one that receives the current standard treatment protocol without bisphosphonates.

Force plate gait analysis, owner questionnaires, veterinarian examination and blood and urine measures of bone turnover will be used to evaluate the effect of the addition of bisphosphonates.

Patient Entry Criteria:
There are certain criteria to determine if your pet will qualify for this study. Canine patients presumptively diagnosed with osteosarcoma in any leg whose owners elect palliative radiation treatment are eligible for this study. Presumptive diagnosis will be based on characteristic X-ray appearance of the lesion, signalment, history and clinical signs and possible fine needle aspiration cytology of the lesion. Diagnosis will be confirmed by histological examination of the leg after either amputation or death. Patients should be free of concurrent or metastatic disease, and should be in good health such that they can be anesthetized for the radiation treatment and receive anti-inflammatory medications (e.g. non-steroidal anti-inflammatory drugs such as deracoxib).

Owner Responsibilities:
The owner is responsible for scheduling appointments with the oncology clinical trials coordinator and keeping those appointments as required by study protocol. These appointments will cover both the treatment and follow-up periods. The owner is financially responsible for the initial visit, the standard staging tests and the standard revisit appointments. The costs related to the initial visit and staging are approximately $900-$1000, though these may be somewhat less depending on what tests have already been done by your regular veterinarian.

Owners are responsible for administering any medication prescribed by the primary clinician and advising of any changes or adverse effects.

In the event of limb amputation or patient death at any time in the future, owners are requested to contact the study director or clinical trials staff and commit to histological analysis of the affected leg to confirm the diagnosis of osteosarcoma.

Financial Incentives:
Clients participating in this study will be given special financial considerations. Specifically, the study will pay for costs associated with force plate gait analysis (~$200), blood and urine samples, study drug and administration. Additionally, $300 dollars towards the cost of radiation therapy (total cost is usually ~$600) will be provided. Cost of histology at Colorado State University for confirmation of diagnosis of osteosarcoma after either amputation or death will be paid for by the study.

Funding for part of this study is provided by a donation from Bone Cancer Dogs Inc, a 501(c)3 non-profit organization that provides information and owner resources for pet owners with dogs affected by bone cancer.

Please contact our Consultation Coordinator at (970) 297-4195 if you are interested in learning more about clinical trials.