A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06065449
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Bone Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Radiation Therapy — DRUG
    Arm 1: standard 8 Gy delivered in a single fraction or 20 Gy delivered in 5 fractions Arm 2: 16 Gy delivered in a single fraction or 27 Gy delivered in 3 fractions prescribed to planning target volume (PTV).

Study Details

To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.

Key Dates

Start date
Jan 24, 2024
Status verified
Jan 2026
Primary completion
Jun 27, 2027
Completion
Jun 27, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - Standard Dose
    Participants will receive either 1 radiation treatment a day for 3 days in a row (not counting weekends or holidays), or Participants will receive 1 radiation treatment given on 1 day.
  • Experimental: Arm 2 - High Dose
    Participants will receive either 1 radiation treatment a day for 5 days, or 1 radiation treatment given on 1 day.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion: an average of 1year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Quynh Nguyen, M D
[email protected]
713-563-2450
Quynh Nguyen,, M D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

Related Studies