Trial Of PreoperAtive Radiation (TOPAz): A Randomized Trial Comparing Hypofractionated Versus Conventionally Fractionated Preoperative Radiation Followed by Mastectomy With Immediate Autologous Breast Reconstruction With Integrated Nanomechanical Biomarker Evaluation

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05774678
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Group 1 (preoperative radiation hypofractionated) — RADIATION
    radiation schedules/regimens before your scheduled breast surgery
  • Group 2 (preoperative radiation conventionally fractionated) — OTHER
    radiation schedules/regimens before your scheduled breast surgery

Study Details

To compare the outcomes of and responses to 2 different radiation therapy schedules (the standard radiation amount and number of doses versus less radiation and fewer doses) that are being given before having breast cancer surgery (cancer removal and reconstruction).

Key Dates

Start date
Apr 5, 2023
Status verified
Dec 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2028

Study Design

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

Arms

  • Experimental: Group 1 (preoperative radiation hypofractionated)
    Participants will receive the standard number of radiation treatment doses
  • Experimental: Group 2 (preoperative radiation conventionally fractionated)
    Participants will receive the standard number of radiation treatment doses

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 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Benjamin D. Smith, MD
[email protected]
713-563-2380
Benjamin D. Smith, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
M D Anderson Cancer Center· Houston, TX

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