Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors

This study has been withdrawn prior to enrollment.
(slow accrual)
Sponsor:
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
  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:
    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.
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014