Trials / Completed
CompletedNCT01215500
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Hypofractionated RT | 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 |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2010-10-06
- Last updated
- 2018-09-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01215500. Inclusion in this directory is not an endorsement.