Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors
This study has been withdrawn prior to enrollment.
(slow accrual)
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00445757
First received: March 7, 2007
Last updated: March 16, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Procedure: conventional surgery Radiation: stereotactic radiosurgery |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors |
Resource links provided by NLM:
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Maximum tolerated dose of radiation [ Time Frame: DLT is assessed at 4 and 8 weeks after radiotherapy ] [ Designated as safety issue: Yes ]
- Radiotherapy-associated toxicity [ Time Frame: DLT is assessed at 4 and 8 weeks after radiotherapy ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Disease-free survival [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ] [ Designated as safety issue: No ]
- Time to local progression [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ] [ Designated as safety issue: No ]
- Time to distant failure [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ] [ Designated as safety issue: No ]
- Survival [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ] [ Designated as safety issue: No ]
- Disease-specific survival [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | January 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: conventional surgery
Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.
Radiation: stereotactic radiosurgery
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445757
Locations
| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | Lee E. Ponsky, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00445757 History of Changes |
| Other Study ID Numbers: | CASE5806, P30CA043703, CASE5806 |
| Study First Received: | March 7, 2007 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
stage I renal cell cancer stage II renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013