Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors
Primary Purpose
Kidney Cancer
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
conventional surgery
stereotactic radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage I renal cell cancer, stage II renal cell cancer
Eligibility Criteria
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
Sites / Locations
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
Maximum tolerated dose of radiation
Radiotherapy-associated toxicity
Secondary Outcome Measures
Disease-free survival
Time to local progression
Time to distant failure
Survival
Disease-specific survival
Full Information
NCT ID
NCT00445757
First Posted
March 7, 2007
Last Updated
March 16, 2012
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00445757
Brief Title
Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors
Official Title
Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Why Stopped
slow accrual
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage I renal cell cancer, stage II renal cell cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum tolerated dose of radiation
Time Frame
DLT is assessed at 4 and 8 weeks after radiotherapy
Title
Radiotherapy-associated toxicity
Time Frame
DLT is assessed at 4 and 8 weeks after radiotherapy
Secondary Outcome Measure Information:
Title
Disease-free survival
Time Frame
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Title
Time to local progression
Time Frame
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Title
Time to distant failure
Time Frame
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Title
Survival
Time Frame
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Title
Disease-specific survival
Time Frame
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee E. Ponsky, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
12. IPD Sharing Statement
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Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors
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