MDACC Study Summary 2010-0559

Study Summary
No. 2010-0559:.......Breast......Benjamin Smith......Radiation Oncology

Study Summary Title



Study Summary Number:	2010-0559

Study Title:	Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma in Situ and Early Invasive Breast Cancer

Physician

New Patient Referral



Name:	Benjamin Smith	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-4982 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Radiation	Home Care:

Treatment Loc:	Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary Objective
To compare patient-reported cosmetic outcome at 3 years using the Breast Cancer Treatment Outcomes Scale (BCTOS) for patients assigned to hypofractionated whole breast irradiation (HF-WBI) versus conventionally fractionated whole breast irradiation (CF-WBI). Specifically, we will compare the 2 treatment arms with respect to the percent of women with adverse cosmetic scores at 3 years after completion of breast conserving surgery, as determined by the patient-reported BCTOS. A score of 2.5 or more indicates an adverse cosmetic outcome.

Secondary Objectives
To determine patient-reported cosmetic outcome using the BCTOS at 6 months, 1, 2, 4, and 5 years.

To determine physician-rated cosmetic outcome at 6 months, 1, 2, 3, 4, and 5 years using the Radiation Therapy and Oncology Group (RTOG) scale for physician assessment. Physician outcome will be determined using photographic assessment and scored by a panel of three attending physicians specializing in breast cancer who will be blinded to the patient randomization arm.

To determine the level of agreement between patient-rated cosmetic outcome and physician-rated cosmetic outcome at the various timepoints assessed.

To determine the 5-year and risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with Ductal carcinoma in situ (DCIS) and early invasive breast cancer.

To determine patient-reported functional status and breast pain using the BCTOS at 6 months, 1, 2, 3, 4, and 5 years after treatment.

To determine maximal acute (within 6 weeks of treatment) and late (more than 6 weeks after treatment) skin and soft tissue toxicities using the NCI CTCAE v4.0 scale.

To determine the relationship between the volume of breast tissue receiving excessive dose (defined as greater than 105% of the prescription dose) and the risk of adverse cosmesis.

To determine the relationship between bra cup size and the risk of adverse cosmesis.

To determine whether there is a statistical interaction between breast volume and volume of tissue receiving greater than 105% of the prescription dose in predicting adverse cosmesis.

To determine in an exploratory analysis whether any other demographic, clinical, and pathologic factors correlate with risk of adverse cosmesis and risk of IBTR.

To determine if the C-509T variant allele of TGF-b is associated with an increased risk of grade 2 or higher fibrosis (as determined by the Subjective, Objective, Medical Management, Analytic [SOMA] scale) three years after completion of radiation.

To compare the cost of radiation for patients treated on the two treatment arms.

To contribute additional blood samples to protocol LAB02-086 which is a case-control study investigating DNA repair phenotypes and genotypes in breast cancer.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/08/2011

Study Type:	Phase Iii

Recruitment Status:	Open

Projected Accrual:	288

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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).

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.

Links

Registration Number: NCT01266642
Study Information on Clinical Trials Registry (clinicaltrials.gov)