Kidney CancerPhase 2NCT00003308
Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma
A Phase 2 study testing stereotactic radiosurgery in people with Kidney Cancer and Melanoma (Skin), run by Eastern Cooperative Oncology Group at 14 sites in 4 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kidney Cancer, Melanoma (Skin), Metastatic Cancer
- What is being tested?
- stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 14 sitesin 4 countries
- Study dates
- 2 Feb 1999to Sep 2004
- Phase
- Phase 2
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma, melanoma, or sarcoma with 1-3 newly diagnosed intraparenchymal brain metastases based on contrast-enhanced MRI (CT scan acceptable if patients have a medical contraindication to MRI)
- No lesion greater than 4.0 cm in diameter and, if multiple lesions are present, no more than one greater than 3.0 cm in diameter
- No limitation on the extent of extracranial metastatic disease
- No metastases in the brain stem, midbrain, pons, or medulla
- No leptomeningeal metastases documented by MRI or CSF evaluation
- No metastases within 10 mm of optic nerve or chiasm
- No history of multiple liver metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 50,000/mm^3
- Hemoglobin greater than 8 g/dL
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No major medical illness
- No psychoses
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy allowed
- Systemic chemotherapy may be continued at the discretion of investigator after completion of radiosurgery
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior cranial radiotherapy
- Prior or concurrent radiotherapy to noncranial sites allowed
Surgery:
- No prior surgical resection for brain metastases
- Prior stereotactic biopsy for diagnostic purposes allowed
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States11 sites
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Mercy Medical Center
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
Alegent Health-Midlands Community Hospital
Papillion, Nebraska, 68128-4157
About this study
Official title: A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.
Read the detailed description
OBJECTIVES:
- Evaluate whether the delivery of stereotactic radiosurgery without conventional whole brain radiotherapy is feasible in patients with 1-3 newly diagnosed brain metastases from renal cell carcinoma, melanoma, or sarcoma.
- Determine the 3-, 6-, and 12-month radiographic and neurologic intracranial patterns of progression (i.e., original lesions vs new lesions) in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to maximum tumor diameter (2 cm vs greater than 2 cm to 3 cm vs greater than 3 cm to 4 cm).
Patients undergo stereotactic radiosurgery at an assigned dose according to tumor diameter. Patients undergo MRI or CT scan at 3, 6, and 12 months after treatment or until disease progression.
All other therapies are allowed after stereotactic radiosurgery except external beam whole brain radiotherapy or resection of brain metastases, unless there is documented progression or unrelenting mass effect that necessitates craniotomy.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 7.2 months.
- Conditions
- Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Sarcoma
- Being tested
- stereotactic radiosurgery
- Keywords
- metastatic osteosarcoma, chondrosarcoma, stage IV renal cell cancer, stage IV melanoma, tumors metastatic to brain, stage IV uterine sarcoma, ovarian sarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, stage IV adult soft tissue sarcoma
- Medical subject headings
- Kidney Neoplasms, Melanoma, Neoplasm Metastasis, Ovarian Neoplasms, Sarcoma, Osteosarcoma, Chondrosarcoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiosurgeryRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start2 Feb 1999
- Primary completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Minesh P. Mehta, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003308
- Sponsor's protocol ID
- CDR0000066255
- Other IDs
- E-6397
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 22 Jun 2023
- Results posted
- No
Publications
Manon R, O'Neill A, Knisely J, Werner-Wasik M, Lazarus HM, Wagner H, Gilbert M, Mehta M; Eastern Cooperative Oncology Group. Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma: an Eastern Cooperative Oncology Group study (E 6397). J Clin Oncol. 2005 Dec 1;23(34):8870-6. doi: 10.1200/JCO.2005.01.8747.
PubMed 16314647
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma
- ClinicalTrials.gov ID
- NCT00003308
- Acronym / sponsor ID
- CDR0000066255
- Conditions
- Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Sarcoma
- Keywords
- metastatic osteosarcoma, chondrosarcoma, stage IV renal cell cancer, stage IV melanoma, tumors metastatic to brain, stage IV uterine sarcoma, ovarian sarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Feb 1999 (actual)
- Primary completion
- Sep 2004 (actual)
- First posted
- 27 Jan 2003 (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: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.
Detailed description
OBJECTIVES:
- Evaluate whether the delivery of stereotactic radiosurgery without conventional whole brain radiotherapy is feasible in patients with 1-3 newly diagnosed brain metastases from renal cell carcinoma, melanoma, or sarcoma.
- Determine the 3-, 6-, and 12-month radiographic and neurologic intracranial patterns of progression (i.e., original lesions vs new lesions) in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to maximum tumor diameter (2 cm vs greater than 2 cm to 3 cm vs greater than 3 cm to 4 cm).
Patients undergo stereotactic radiosurgery at an assigned dose according to tumor diameter. Patients undergo MRI or CT scan at 3, 6, and 12 months after treatment or until disease progression.
All other therapies are allowed after stereotactic radiosurgery except external beam whole brain radiotherapy or resection of brain metastases, unless there is documented progression or unrelenting mass effect that necessitates craniotomy.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 7.2 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| stereotactic radiosurgery | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 16314647Manon R, O'Neill A, Knisely J, Werner-Wasik M, Lazarus HM, Wagner H, Gilbert M, Mehta M; Eastern Cooperative Oncology Group. Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma: an Eastern Cooperative Oncology Group study (E 6397). J Clin Oncol. 2005 Dec 1;23(34):8870-6. doi: 10.1200/JCO.2005.01.8747.
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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.
Minesh P. Mehta, MD study chair
University of Wisconsin, Madison
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stereotactic radiosurgery in people with Kidney Cancer and Melanoma (Skin), run by Eastern Cooperative Oncology Group at 14 sites in 4 countries.
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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Australia, Peru, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003308, which also lists 1 linked publication.
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 Jun 2023.