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 range

18 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2010-05

Results submitted2012-08-20

View on ClinicalTrials.gov More Kidney Cancer trials