Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors

March 16, 2012 updated by: Case Comprehensive Cancer Center

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

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors.

Study Overview

Status

Withdrawn

Conditions

Kidney Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

Determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors.
Determine radiotherapy-associated toxicity in these patients.

Secondary

Determine preoperative pathologic response to this regimen in these patients.

OUTLINE: This is a dose-escalation study of radiotherapy.

Radiotherapy: Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached. The MTD is defined as the dose preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting toxicity (DLT). DLT is assessed at 4 and 8 weeks after radiotherapy.
Surgery: Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.

After completion of study therapy, patients are followed periodically for at least 2 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Type

Interventional

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Cleveland, Ohio, United States, 44106-5065
    - Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Radiologically confirmed renal tumor
- At least 4 cm in greatest dimension
No clinically, radiologically, or pathologically involved lymph nodes
No distant metastases

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
Negative pregnancy test
Fertile patients must use effective contraception
Medically eligible for tumor resection
No major medical condition or psychiatric illness that would preclude study compliance
No active connective tissue disease, such as lupus or dermatomyositis
No active Crohn's disease or active ulcerative colitis

PRIOR CONCURRENT THERAPY:

No prior chemotherapy
No prior abdominal or pelvic radiotherapy
No prior cryosurgery
No prior radiofrequency ablation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose of radiation Time Frame: DLT is assessed at 4 and 8 weeks after radiotherapy	DLT is assessed at 4 and 8 weeks after radiotherapy
Radiotherapy-associated toxicity Time Frame: DLT is assessed at 4 and 8 weeks after radiotherapy	DLT is assessed at 4 and 8 weeks after radiotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to local progression Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to distant failure Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Survival Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Disease-specific survival Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Lee E. Ponsky, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)