Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses
Jonsson Comprehensive Cancer Center
Summary
This phase I/II trial investigates the side effects of interstitial brachytherapy and to see how well it works in limiting the growth of large kidney cancer masses in patients with kidney cancer that have refused or are unable to undergo surgery or ablation (unresectable/unablatable). Brachytherapy, also known as internal radiation therapy, temporarily introduces a radiation source into or near the tumor to eradicate the tumor cells. Giving brachytherapy may potentially reduce the size of the kidney cancer mass that would otherwise not be amenable to surgical management and translate into lower risk of spread.
Description
PRIMARY OBJECTIVES: I. To determine the safety and feasibility of renal interstitial radiation therapy (interstitial brachytherapy). (Safety Lead-In) II. To evaluate local control of renal interstitial brachytherapy. (Expansion Phase) SECONDARY OBJECTIVES: I. To evaluate treatment response of the primary tumor. II. To evaluate 12 month distant progression free survival. III. To evaluate the 12 month volumetric growth of the primary tumor mass. IV. To determine biomarkers predicting response and resistance to radiation treatment. OUTLINE: Patients undergo interstitial brachytherapy for 1-2…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Elected to undergo interstitial brachytherapy as part of conventional treatment for renal cell carcinoma * Biopsy proven renal cell carcinoma * No definitive evidence of locally advanced (nodal or tumor thrombus) or distant (metastatic) disease * Lesion size (maximal dimension) of 4 to 10 cm * Patient not a candidate for curative surgery (unwilling or unable to pursue surgery) * Lesion cannot be reliably treated with ablative techniques * Entire lesion able to be treated adequately by brachytherapy per radiation oncologist * Tumor predominantly solid (\~ \> 80%) * Lesion…
Interventions
- ProcedureInterstitial Radiation Therapy
Undergo interstitial brachytherapy
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California