CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 167 enrolled
Drug / intervention
Hypofractionated Radiation Treatment +2 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02163226
NCT02163226Phase 3Completed

A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms

M.D. Anderson Cancer Center·interventional·Posted Jun 13, 2014·Updated Nov 8, 2021

In Brief

A Phase 3 clinical trial evaluating Hypofractionated Radiation Treatment, One Radiation Treatment, and 1 other intervention for Bone Metastases. Completed, enrolled 167 participants across 3 sites.

Detailed Summary

The goal of this clinical research study is to learn if 1 large dose of radiation therapy is better at controlling pain from cancer that has spread to the bones than 10 smaller doses of radiation. Researchers also want to learn if 1 large dose of radiation therapy can help decrease the use of drugs to control the pain, and if it can help to control the disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Metastases
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 13, 2014
Enrollment StartAug 6, 2014
Primary CompletionSep 2, 2020
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 12.1 years ago

Interventions

Hypofractionated Radiation Treatmentradiation

Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row.

One Radiation Treatmentradiation

12 Gy x 1 fraction or 16 Gy x 1 fractions adaptively depending on the size of the metastases or gross tumor volume (GTV).

Questionnairebehavioral

Questionnaire completion at months 1, 2, 3, 4, and 6 and then every 3 months after that for at least 3 years. Questionnaires ask about pain, pain relief, and quality of life.