Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00445757
• Other study ID #: CASE5806
• Secondary ID: P30CA043703CASE5
• Status: Withdrawn
• Phase: Phase 1
• First received: March 7, 2007
• Last updated: March 16, 2012
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2012
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of radiation		DLT is assessed at 4 and 8 weeks after radiotherapy	Yes
Primary	Radiotherapy-associated toxicity		DLT is assessed at 4 and 8 weeks after radiotherapy	Yes
Secondary	Disease-free survival		follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	No
Secondary	Time to local progression		follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	No
Secondary	Time to distant failure		follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	No
Secondary	Survival		follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	No
Secondary	Disease-specific survival		follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery	No