MDACC Study Summary RTOG0413

Study Summary
No. RTOG0413:.......Breast......Eric A. Strom......Radiation Oncology

Study Summary Title



Study Summary Number:	RTOG0413

Study Title:	A Randomized Phase III Study of Conventional Breast Irradiation (WBI) versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer

Physician

New Patient Referral



Name:	Eric A. Strom	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:	713-563-2356 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	For the first year, at 4 weeks, 6 months, and 12 months following therapy; then every 6 months for 4 years, then yearly thereafter.

Treatment Agents:	Radiation	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to see if a 1-week course of partial breast irradiation is more effective than a 6-week course of whole breast radiation treatment for keeping cancer from coming back in the breast while keeping a good cosmetic outcome.

Study Objectives / Outcomes

Primary aim

To determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provides equivalent local tumor control in the breast compared to conventional whole breast irradiation (WBI) in the local management of early stage breast cancer.

Secondary aims

To compare overall survival, recurrence-free survival, and distant disease-free survival between women receiving PBI and women receiving WBI.
To determine whether PBI delivered on 5 treatment days over a period of 5 to 10 days can provide a comparable cosmetic result to WBI.
To determine if PBI produces less fatigue and treatment-related symptoms compared to WBI.
To determine if perceived convenience of care is greater for women receiving PBI compared to women receiving WBI.
To compare acute and late toxicities between the radiation therapy regimens.

Study Status Information



Study Activation / Registration Date:	08/09/2005

IRB Review and Approval Date:	06/01/2005

Study Type:	Not Applicable

Recruitment Status:	Closed

Projected Accrual:	4300

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) The patient must have stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.

2) On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.

3) Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCTS and invasive). Re- excision of surgical margins is permitted.

4) Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)

5) Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is not required for patients with DCIS.)

6) The patient must be randomized within 42 days following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).

7) Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must be performed. If ER analysis is positive, PgR analysis is desired but not mandatory. ("Marginal" or "borderline" results [i.e., those not definitively negative] will be considered positive regardless of the methodology used.)

8) The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be </= 30% based on the postoperative/pre-randomization CT scan.

9) Patients are eligible if, based on the postoperative/pre-randomization CT scan, PBI is judged to be technically deliverable by a technique for which the radiation oncology facility has been credentialed.

10) Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

11) Patients must be >/= 18 years old.

Exclusion Criteria:

1) Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study.

2) T2(>3.0 cm), T3, stage III, or stage IV breast cancer.

3) More than 3 histologically positive axillary nodes.

4) Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.

5) Any positive non-axillary node(s). (Intramammary nodes are staged as axillary nodes).

6) Suspicious microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.

7) Non-epithelial breast malignancies such as sarcoma or lymphoma.

8) Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters.

9) Paget's diesease of the nipple.

10) Synchronous bilateral invasive or non-invasive breast cancer.

11) History of invasive breast cancer or DCIS. (Patients with a history of LCIS treated by surgery alone are eligible).

12) Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (if surgical margins are rendered free of diesease by re-excision, the patient is eligible).

13) Any treatment with radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exception is hormonal therapy, which may have been given for no more than a total of 28 days before randomization.

14) Current therapy with any hormonal agents such as raloxifene (Evista�), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization).

15) Breast implants. (Patients who have had implants removed are eligible).

16) Prior breast or thoracic RT for any condition.

17) Collagen vascular diesease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.

18) Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.

Links

Registration Number: NCT00103181
Study Information on Clinical Trials Registry (clinicaltrials.gov)