CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
Hypofractionated Simultaneous Integrated Boost Radiotherapyradiation
Likely dose
2.66 Gy per day for 15 fractions with simultaneous integrated boostAI-extracted
Key inclusion· 5
  • Prior chemotherapy for breast cancer (optional inclusion criterion)
  • Greater than 25 cm breast separation on planning CT
  • Non-Caucasian race (optional inclusion criterion)
  • Age 50 years or younger
Key exclusion· 2
  • Male sex
  • Pregnant or nursing women

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

Search/NCT03167359
NCT03167359N/ACompleted

A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients

Emory University·interventional·Posted May 30, 2017·Updated May 7, 2021

In Brief

A clinical study evaluating Hypofractionated Simultaneous Integrated Boost Radiotherapy for Cancer, Breast and Inflammation. Completed, enrolled 74 participants across 1 site.

Detailed Summary

As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT. The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.

Study Details

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

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartDec 1, 2010
Primary CompletionMay 14, 2019
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 9.1 years ago

Interventions

Hypofractionated Simultaneous Integrated Boost Radiotherapyradiation

Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.