NCT01215500|CompletedPhase 1
Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
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A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
Sponsor study identifier
interventional
63
1 country
1
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2018
Actual (reported)Study Completion
March 2018
Actual (reported)Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy. The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 2, 2010
Actual (reported)October 6, 2010
Actual (reported)March 2018
Actual (reported)March 2018
Actual (reported)Dose-limiting toxicities
The dose limiting toxicities occurring within the initial observation period will be defined.
30-90 days
maximum tolerated dose of hypofractionated RT
30-90 days
RT to site of metastatic disease for three fractions separated by 3 to 8 days. Doses of radiation will increase as follows in order to determine the MTD in Gy: For all sites the dose levels are as follows: 1. 8 Gy/ fraction x 3 fractions = 24 Gy 2. 10 Gy/fraction x 3 fractions = 30 Gy 3. 12 Gy/fraction x 3 fractions = 36 Gy 4. 14 Gy/fraction x 3 fractions = 42 Gy 5. 16 Gy/fraction x 3 fractions = 48 Gy 6. 18 Gy/fraction x 3 fractions = 52 Gy 7. 20 Gy/fraction x 3 fractions = 60 Gy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Chicago
Chicago, Illinois, 60637, United States
Steven Chmura, MD
University of Chicago
63 participants (actual enrollment reported by the registry).
First Submitted
August 2, 2010
First Posted
October 6, 2010
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study to Investigate the Therapeutic Role of RNA Fragments in Platelet Production During Chemotherapy
Contact the study team to confirm eligibility.
Primary Completion
March 2018
Actual (reported)Study Completion
March 2018
Actual (reported)Last Updated
September 12, 2018
Record last verified: 2018-09
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Source: ClinicalTrials.gov.
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