Skip to main content
OpenTrials
Completed

NCT Number: NCT00458484

Radiosurgery in Treating Patients With Kidney Tumors

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Loading trial locations.

About this study

OBJECTIVES:

Primary

  • To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.

Secondary

  • To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.

Serum Blood Marker Objective:

  • To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.

After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)
  • Patient is able to give and sign study specific informed consent
  • No prior radiation to the treatment field
  • Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
  • Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
  • Karnofsky status of ≥ 60%
  • Signed study-specific informed consent prior to study entry

Exclusion criteria

  • Any patient not meeting the eligibility criteria.
  • Any patient with active connective tissue disease such as lupus, dermatomyositis.
  • Any patient with active Crohn's disease or active ulcerative colitis.
  • Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.

Treatment and study plan

Stereotactic Radiosurgery

Radiation

Series I: Radiation will be delivered in 4 fractions.

Series II: Radiation will be delivered in 3 fractions.

Renal Biopsy

Procedure

At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers

Procedure

ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Primary outcomes

  1. Maximum Tolerated Dose of Radiosurgery

    Time frame: once every 4 weeks

    Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.

Secondary outcomes

  1. Overall Survival

    Time frame: at 36 months from start of therapy

    Radiographic efficacy as measured by overall (percent of participants still alive after study completion)

  2. Progression-free Survival

    Time frame: at 36 months from start of therapy

    Percent of participants still alive and without tumor progression at study completion

  3. Freedom From Local Progression

    Time frame: at 36 months from start of therapy

    Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)

  4. Freedom to Distant Recurrence

    Time frame: at 36 months from start of therapy

    Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates

Important dates

Study start
2007
Primary completion
2017
Study completion
2019
First posted
Apr 11, 2007
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.