Therapeutic Intervention of Radiation-Induced Dermatitis for Canine Cancers Treated with Radiation Therapy

Patient Disease:

Canine Soft Tissue Sarcoma

Study Name:

Therapeutic Intervention of Radiation-Induced Dermatitis for Canine Cancers Treated with Radiation Therapy

Purpose of the study:

  • To determine if radiation dermatitis is diminished when treated with the novel drug compared to a placebo and to determine appropriate dosing required to observe an effect

  • Monitor for any unexpected toxicity associated with the treatment.

Primary Eligibility Criteria:

  • Dogs with a confirmed diagnosis of grade I or II soft tissue sarcoma that has been incompletely excised

  • No evidence of metastatic disease (spread)

  • No prior radiation therapy to tumor; no concurrent chemotherapy during study

  • No gross disease present at surgical site

  • Surgical site must be well-healed at the time of starting radiation

  • Good function of liver and kidneys, acceptable blood cell counts, and free of severe underlying disease

Study Protocol:

  • All dogs will receive the standard radiation therapy protocol for dogs with incompletely excised soft tissue sarcomas, which consists of 18 daily (M-F) treatments

  • The study treatment will begin on the day of the 10th radiation treatment with small amounts of the study drug or placebo injected around the radiation field at 1 cm intervals at every other treatment

  • Two-thirds of the dogs enrolled in the study will have half of the radiation field treated with the study drug and half of the field treated with a placebo; the other third of dogs will be treated with placebo only

  • Blood samples and skin biopsies within the radiation field will be collected prior to the first radiation treatment, prior to the 10th treatment, and at the time of the final treatment

  • Rechecks 1, 2, and 4 weeks after the completion of the radiation protocol will be required for continued evaluation of radiation side effects

Owner Responsibilities:

  • Follow appointment schedule required by study protocol

  • The radiation therapy planning and treatment accounts for $4050 of the total cost of radiation. As an incentive, owners will pay $1000 towards the radiation planning/therapy portion, meaning that the total incentive is valued at $3050.

  • Owners will be responsible for all other costs associated with the treatment. This includes any medications, medical boarding, e-collars, routine blood work that is always required for radiation patients and other costs.

Financial Incentives:

  • All procedures related to the study (biopsies, blood sample collection, and study treatment) will be covered by the study

  • The study will also cover the cost of the exam at the 1, 2, and 4 weeks post-treatment rechecks

  • The costs of treatment of any side effects deemed to be secondary to the study treatment or procedures will be covered by the study

If you have further questions about any of our clinical trials, please submit an online consulting form. Your consult will then be directed to an appropriate oncology clinician. Requests are typically returned within 5 business days.