Kidney CancerPhase 1NCT00445757
Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors
A Phase 1 study testing conventional surgery and stereotactic radiosurgery in people with Kidney Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- conventional surgery and stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors
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.
Read the 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.
- Conditions
- Kidney Cancer
- Being tested
- conventional surgery, stereotactic radiosurgery
- Keywords
- stage I renal cell cancer, stage II renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of radiation
Measured: DLT is assessed at 4 and 8 weeks after radiotherapy
Radiotherapy-associated toxicity
Measured: DLT is assessed at 4 and 8 weeks after radiotherapy
Secondary outcomes (5)
Disease-free survival
Measured: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to local progression
Measured: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to distant failure
Measured: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Survival
Measured: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Disease-specific survival
Measured: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lee E. Ponsky, MD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445757
- Sponsor's protocol ID
- CASE5806
- Other IDs
- P30CA043703, CASE5806
- Status last verified
- Mar 2012
- First submitted
- 7 Mar 2007
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors
- ClinicalTrials.gov ID
- NCT00445757
- Acronym / sponsor ID
- CASE5806
- Conditions
- Kidney Cancer
- Keywords
- stage I renal cell cancer, stage II renal cell cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgeryTwo months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy. | Procedure or surgery | – |
| stereotactic radiosurgeryPatients 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. | Radiation | – |
Primary outcome
Maximum tolerated dose of radiation
Time frame: DLT is assessed at 4 and 8 weeks after radiotherapy
Radiotherapy-associated toxicity
Time frame: DLT is assessed at 4 and 8 weeks after radiotherapy
5 secondary outcomes
Disease-free survival
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to local progression
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to distant failure
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Survival
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Disease-specific survival
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee E. Ponsky, MD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing conventional surgery and stereotactic radiosurgery in people with Kidney Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of radiation (time frame: DLT is assessed at 4 and 8 weeks after radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.