Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.

Interstitial Radiation Therapy

Bashir Wyatt

Albert J. Chang

Albert J Chang

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.

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 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.

After completion of study treatment, patients are followed up every 3 months for at least 3 years.

Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses

A 3+3 safety lead-in phase will be employed in order to determine the DLT for interstitial renal brachytherapy. Grading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events version 5.0 criteria.

Adequate local control will be defined as minimal growth kinetics (=\< 1 mm/year) on 1 year follow-up.

Jonsson Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer	NCT04473781	Stage I Renal C... Stage II Renal ...	Interstitial Ra...	18 Years -	Jonsson Comprehensive Cancer Center
Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer	NCT04473781	Stage I Renal C... Stage II Renal ...	Interstitial Ra...	18 Years -	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for interstitial radiation therapy