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| ID | Type | Description | Link |
|---|---|---|---|
| ICR-IMPORT-HIGH | |||
| ICR-CTSU/2007/10013 | |||
| ISRCTN47437448 | |||
| EU-20897 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (control) | Active Comparator | Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy). |
|
| Arm II | Experimental | Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy). |
|
| Arm III | Experimental | Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensity-modulated radiation therapy | Radiation | Given as 48, 53, or 56 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Palpable induration inside the boost volume of the irradiated breast |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
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DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer
Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| John R. Yarnold, MD, FRCR | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Marsden - Surrey | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
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| Location of tumor relapse in breast |
| Contralateral primary tumors |
| Regional and distant metastases |
| Overall survival |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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