Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain (NCT00550654) | Clinical Trial Compass
TerminatedPhase 2
Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain
Stopped: Study was terminated due to poor accrual.
United States1 participantsStarted 2007-10
Plain-language summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well conformal radiation therapy works in treating patients with metastatic cancer outside the brain.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Pathologically confirmed cancer
* No active disease at the primary site as assessed by physical examination, clinical evaluation, or site-specific imaging
* Measurable metastatic disease meeting the following criteria:
* Four or fewer sites of extracranial lesions \< 5 cm in size
* If metastatic site(s) is within the lung, the following criteria must be met:
* No more than two metastases in the proximal bronchial tree area (defined as 2 cm from the trachea or mainstem bronchi)
* Carbon monoxide diffusing capacity (DLCO) \> 30% predicted and forced expiratory volume 1 (FEV1) \> 1.2 L (in patients with more than one metastatic site in the lungs)
* If metastatic site(s) is within 2 cm of either kidney, creatinine level must be \< 1.5 times upper limit of normal (ULN)
* If metastatic site(s) is within 2 cm of the liver, bilirubin level must be \< 1.5 times ULN
* Patients with metastatic disease that meets any of the following criteria are excluded:
* Proposed site(s) of treatment has been previously treated with radiotherapy
* Metastatic site(s) requires emergent treatment (e.g., spinal cord compression, cauda equina, airway compromise, or life-threatening end-organ dysfunction)
* Disease that is untreated or previously treated and progressive in the brain
* Pathologic fracture or impending pathologic fracture at the metastatic site
* Metastatic site(s) of a disease histology that is known to be sensitive to low doses of…
What they're measuring
1
6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease
Timeframe: 6 months
Trial details
NCT IDNCT00550654
SponsorNational Institutes of Health Clinical Center (CC)