Kidney CancerNCT00458484
Radiosurgery in Treating Patients With Kidney Tumors
A study testing stereotactic radiosurgery, Renal Biopsy and Serum Blood Markers in people with Kidney Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery. 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?
- stereotactic radiosurgery, Renal Biopsy and Serum Blood Markers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Feb 2007to 12 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)
- Patient is able to give and sign study specific informed consent
- No prior radiation to the treatment field
- Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
- Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
- Karnofsky status of ≥ 60%
- Signed study-specific informed consent prior to study entry
Who cannot join
- Any patient not meeting the eligibility criteria.
- Any patient with active connective tissue disease such as lupus, dermatomyositis.
- Any patient with active Crohn's disease or active ulcerative colitis.
- Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
UH-Chagrin Highlands
Orange, Ohio, 44122
UH-Westlake
Westlake, Ohio, 44145
About this study
Official title: Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates
RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.
Secondary
- To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.
Serum Blood Marker Objective:
- To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.
After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- stereotactic radiosurgery, Renal Biopsy, Serum Blood Markers
- Keywords
- stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV 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.
stereotactic radiosurgeryRadiation
Series I: Radiation will be delivered in 4 fractions.
Series II: Radiation will be delivered in 3 fractions.
Renal BiopsyProcedure or surgery
At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
Serum Blood MarkersProcedure or surgery
ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
| Study group | Role | What they receive |
|---|---|---|
| Series 1: Stereotactic radiosurgery | Experimental | Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy. Receives: Radiation: stereotactic radiosurgery; Procedure: Renal Biopsy; Procedure: Serum Blood Markers |
| Series 2: Stereotactic radiosurgery | Experimental | Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each. Receives: Radiation: stereotactic radiosurgery; Procedure: Renal Biopsy; Procedure: Serum Blood Markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Radiosurgery
Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.
Measured: once every 4 weeks
Secondary outcomes (4)
Overall Survival
Radiographic efficacy as measured by overall (percent of participants still alive after study completion)
Measured: at 36 months from start of therapy
Progression-free Survival
Percent of participants still alive and without tumor progression at study completion
Measured: at 36 months from start of therapy
Freedom From Local Progression
Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)
Measured: at 36 months from start of therapy
Freedom to Distant Recurrence
Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)
Measured: at 36 months from start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study start20 Feb 2007
- Primary completion12 Mar 2017
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 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
- Mitchell Machtay, MD, Principal investigator, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458484
- Sponsor's protocol ID
- CASE12806
- Other IDs
- P30CA043703, CASE12806, NCI-2010-01064
- Status last verified
- Jul 2020
- First submitted
- 9 Apr 2007
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. 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 in Poor Surgical Candidates
- ClinicalTrials.gov ID
- NCT00458484
- Acronym / sponsor ID
- CASE12806
- Conditions
- Kidney Cancer
- Keywords
- stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Feb 2007 (actual)
- Primary completion
- 12 Mar 2017 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Posted 22 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.
Detailed description
OBJECTIVES:
Primary
- To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.
Secondary
- To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.
Serum Blood Marker Objective:
- To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.
After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Series 1: Stereotactic radiosurgery | Experimental | Radiation: stereotactic radiosurgery, Procedure: Renal Biopsy, Procedure: Serum Blood MarkersSeries I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy. |
| Series 2: Stereotactic radiosurgery | Experimental | Radiation: stereotactic radiosurgery, Procedure: Renal Biopsy, Procedure: Serum Blood MarkersSeries II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)
- Patient is able to give and sign study specific informed consent
- No prior radiation to the treatment field
- Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
- Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
Key exclusion criteria (4 listed)
- Any patient not meeting the eligibility criteria.
- Any patient with active connective tissue disease such as lupus, dermatomyositis.
- Any patient with active Crohn's disease or active ulcerative colitis.
- Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.
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 |
|---|---|---|
| stereotactic radiosurgerySeries I: Radiation will be delivered in 4 fractions. Series II: Radiation will be delivered in 3 fractions. | Radiation | Series 1: Stereotactic radiosurgery, Series 2: Stereotactic radiosurgery |
| Renal BiopsyAt 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance. | Procedure or surgery | Series 1: Stereotactic radiosurgery, Series 2: Stereotactic radiosurgery |
| Serum Blood MarkersELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF. | Procedure or surgery | Series 1: Stereotactic radiosurgery, Series 2: Stereotactic radiosurgery |
Primary outcome
Maximum Tolerated Dose of Radiosurgery
Time frame: once every 4 weeks
Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.
4 secondary outcomes
Overall Survival
Time frame: at 36 months from start of therapy
Progression-free Survival
Time frame: at 36 months from start of therapy
Freedom From Local Progression
Time frame: at 36 months from start of therapy
Freedom to Distant Recurrence
Time frame: at 36 months from start of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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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.
Mitchell Machtay, MD principal investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic radiosurgery, Renal Biopsy and Serum Blood Markers in people with Kidney Cancer, run by Case Comprehensive Cancer Center at 3 sites 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?
The sponsor lists 7 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Radiosurgery (time frame: once every 4 weeks). 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 22 Jul 2020.