Hypofractionation Trial
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Purpose
The goal of this clinical research study is to compare how 4 weeks of radiation treatment affects the breast to how 6 weeks of radiation treatment affects the breast. Researchers also want to know about other side effects of radiation.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: Hypofractionated Whole Breast Irradiation Radiation: Conventionally Fractionated Whole Breast Irradiation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma in Situ and Early Invasive Breast Cancer |
- Percent Women with Adverse Cosmetic Scores at 3 Years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Comparison of patient-reported cosmetic outcomes using Breast Cancer Treatment Outcomes Scale (BCTOS): 1) Hypofractionated whole breast irradiation (HF-WBI) versus 2) Conventionally fractionated whole breast irradiation (CF-WBI). Number of women with adverse cosmetic scores at 3 years after completion of breast conserving surgery, as determined by the patient-reported BCTOS where a score of 2.5 or more indicates an adverse cosmetic outcome.
| Estimated Enrollment: | 288 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HF-WBI
Shorter radiation (Group 1), Hypofractionated Whole Breast Irradiation (HF-WBI)
|
Radiation: Hypofractionated Whole Breast Irradiation
42.56 Gy in 16 fractions delivered to the whole breast on consecutive treatment days. Boost of 10 Gy in 4 fractions or 12.5 Gy in 5 fractions delivered on consecutive days beginning on treatment day following completion of whole breast irradiation. Other Names:
|
|
Experimental: CF-WBI
Standard radiation (Group 2), Conventionally Fractionated Whole Breast Irradiation (CF-WBI)
|
Radiation: Conventionally Fractionated Whole Breast Irradiation
50 Gy in 25 fractions delivered to whole breast on consecutive treatment days. Boost of 10 Gy in 5 fractions or 14 Gy in 7 fractions delivered on consecutive treatment days, beginning on treatment day following completion of whole breast irradiation. Other Names:
|
Detailed Description:
Study Questionnaire and Photographs:
If you agree to take part in this study, you will complete questionnaires about your general health and how your breast currently looks and feels. This should take about 15 minutes to complete. Photographs will also be taken of your breast and your doctor will rate the way your breast looks before you begin receiving radiation. You will not be able to be identified in the photographs. The photographs will be kept as part of your medical record. You will also have a physical exam and your medical history will be recorded.
Study Groups:
You will then be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will receive shorter radiation. Group 2 will receive standard radiation.
For shorter radiation (Group 1), you will receive about 3 weeks of radiation (16 treatments) to the entire breast. You will also have 4-5 additional treatments of radiation as a "boost". The boost will be delivered to the part of the breast where the disease first started.
For standard radiation (Group 2), you will receive about 5 weeks of radiation (25 treatments) to the entire breast. You will also have 5-7 additional treatments of radiation as a boost to the part of the breast where the disease started.
Study Visits:
While you are receiving radiation, you will be asked about any side effects you may be having each week.
Follow-up Visit:
You will return to the clinic for follow-up visits 6 months and 1, 2, 3, 4, and 5 years after you have finished receiving radiation. At each follow-up visit, you will fill out the study questionnaire, more photographs will be taken of your breast, and you will be asked about any side effects you may be having. You will also have a physical exam and your medical history will be recorded.
Length of Study:
After the 5-year follow-up visit, you will be off study.
This is an investigational study. Both the standard and the shorter radiation courses are FDA-approved in patients with breast cancer. The goal of this study is to compare the 2 treatments.
Up to 288 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with DCIS only).
- Treatment with breast conserving surgery.
- Final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin. If the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a reexcision is strongly encouraged. Lobular carcinoma in situ at the final surgical margin will be disregarded.
- Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences.
- Female sex.
- Attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level I/II axilla with high tangents is allowed).
- If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.
- Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy.
Exclusion Criteria:
- Pathologic or clinical evidence for a stage T3 or T4 breast cancer.
- Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes.
- Clinical or pathologic evidence for distant metastases.
- Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast.
- Current diagnosis of bilateral breast cancer.
- History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast.
- Patients not fluent in English or Spanish. (The Informed Consent will be available in these two languages)
- Patient is pregnant.
Contacts and Locations| Contact: Benjamin Smith, MD | 713-794-4982 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Benjamin Smith, MD | |
| Principal Investigator: | Benjamin Smith, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01266642 History of Changes |
| Other Study ID Numbers: | 2010-0559 |
| Study First Received: | December 20, 2010 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Breast cancer Early invasive breast cancer Ductal carcinoma in situ of the breast Tis T1 T2 N0 N1mic |
N1a Lumpectomy Hypofractionated whole breast irradiation HF-WBI Conventionally fractionated whole breast irradiation CF-WBI Radiation therapy Radiotherapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on May 22, 2013