NCT00445757

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

3.2 years

First QC Date

March 7, 2007

Last Update Submit

March 16, 2012

Conditions

Kidney Cancer

Keywords

stage I renal cell cancerstage II renal cell cancer

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of radiation

    DLT is assessed at 4 and 8 weeks after radiotherapy

  • Radiotherapy-associated toxicity

    DLT is assessed at 4 and 8 weeks after radiotherapy

Secondary Outcomes (5)

  • Disease-free survival

    follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery

  • Time to local progression

    follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery

  • Time to distant failure

    follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery

  • Survival

    follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery

  • Disease-specific survival

    follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery

Interventions

conventional surgeryPROCEDURE

Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.

stereotactic radiosurgeryRADIATION

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Lee E. Ponsky, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 9, 2007

Study Start

January 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(1)