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Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
NCT01223248 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to find out which way of giving high-dose radiation works best for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days) or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the exposure to normal tissue. Currently there are no studies that compare the effects of giving radiation in either hypofractionated doses (higher total doses of radiation spread out over several treatment days) or a single-fraction dose (entire radiation dose given in one treatment session). The patient may be asked to participate in an additional part of this study where we will get a a (DW/DCE) MRI before treatment start and within one hour after radiation treatment. If the patient is asked to take part in this portion of the study, all they will need to do is get up to 3 MRIs with standard contrast injection. The purpose of this is to see if as a result of the treatment there are changes in the blood flow going to the cancer which could suggest that the treatment may be successful. In addition some patients can present new lesions and may be asked if they would like to have these new lesions treated on the protocol. If they are given this option, this will not extend their follow up period. The follow up of the new lesions will match with the prior follow up dates.
Conditions Studied
Interventions
- RADIATION IGIMRT using a single dose of 24 Gy
- RADIATION IGIMRT 27 Gy in 3 fractions
Study Locations (4)
Other
- University of Pisa — Pisa
- The Champalimaud Centre — Lisbon
California
- University of California San Francisco — San Francisco
New York
- Memorial Sloan Kettering Cancer Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2010-10 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01223248
The ClinicalTrials.gov registry entry for NCT01223248 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions — of which IGIMRT using a single dose of 24 Gy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01223248 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01223248 about?
NCT01223248 is a clinical study titled "Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy". The purpose of this study is to find out which way of giving high-dose radiation works best for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days) or 24 Gy in one fract...
What is the current status of trial NCT01223248?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2010-10. Estimated completion is 2026-10.
What conditions does trial NCT01223248 study?
This clinical trial studies the following conditions: Ovarian Cancer, Melanoma, Sarcoma, Soft Tissue, Bone. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01223248?
The interventions under investigation include: IGIMRT using a single dose of 24 Gy (RADIATION), IGIMRT 27 Gy in 3 fractions (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01223248?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01223248 being conducted?
This trial has 4 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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