Hypofractionation Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01266642
First received: December 20, 2010
Last updated: August 12, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 2016 (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:
  • Radiation therapy
  • Radiotherapy
  • HF-WBI
  • XRT
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:
  • Radiation
  • radiotherapy
  • Radial Therapy
  • XRT
  • CF-WBI

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
Criteria

Inclusion Criteria:

  1. 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). (Upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy. For such patients, the criteria for pathologic stage shall be applied to the initial clinical stage)
  2. Treatment with breast conserving surgery.
  3. 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.
  4. 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.
  5. Female sex.
  6. 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).
  7. 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.
  8. 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:

  1. Pathologic or clinical evidence for a stage T3 or T4 breast cancer.
  2. Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes.
  3. Clinical or pathologic evidence for distant metastases.
  4. Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast.
  5. Current diagnosis of bilateral breast cancer.
  6. History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast.
  7. Patients not fluent in English or Spanish. (The Informed Consent will be available in these two languages)
  8. Patient is pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266642

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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, NCI-2011-00253
Study First Received: December 20, 2010
Last Updated: August 12, 2014
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
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 September 30, 2014