A Phase 3 interventional study of intensity-modulated radiation therapy in Breast Cancer, sponsored by Institute of Cancer Research, United Kingdom. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-07.
Sponsored by Institute of Cancer Research, United Kingdom · Phase 3, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which radiation therapy schedule is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.
Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years. Blood samples are collected at baseline and periodically thereafter. Tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor.
After completion of study treatment, patients are followed annually for 10 years.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 840 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institute of Cancer Research, United Kingdom is the lead sponsor of 113 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
Radiation: intensity-modulated radiation therapy
Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
Radiation: intensity-modulated radiation therapy
Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).
Radiation: intensity-modulated radiation therapy
Given as 48, 53, or 56 Gy
Palpable induration inside the boost volume of the irradiated breast
Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires)
Local tumor control
Location of tumor relapse in breast
Contralateral primary tumors
Regional and distant metastases
Overall survival
This study is status unknown, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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