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NCT01223248 · ClinicalTrials.gov registry record · Phase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
A Phase 3 study of Ovarian Cancer and Melanoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 4
- Study locations
NCT01223248: Active Phase 3 study of Ovarian Cancer and Melanoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01223248 is a Phase 3 study of Ovarian Cancer and Melanoma that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 220 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (70% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01223248, a Phase 3 study of Ovarian Cancer and Melanoma, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
a single dose of 24 Gy versus 27 Gy in three fractions for patients with metastatic disease
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 |
What the registry record for NCT01223248 still lists
NCT01223248 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (70% lower).
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.
NCT01223248 reports a single indexed study location in Other, California, New York.
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.
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).
Who is sponsoring clinical trial NCT01223248?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01223248's enrollment target sits among peer trials
220 88th of 322 higher than 233 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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