MDACC Study Summary RTOG1014

Study Summary
No. RTOG1014:.......Breast......Wendy A. Woodward......Radiation Oncology

Study Summary Title



Study Summary Number:	RTOG1014

Study Title:	A Phase II study of repeat breast preserving surgery and 3-D Conformal Partial Breast Re-Irradiation (PBRI) for Local Recurrence of Breast Carcinoma

Physician

New Patient Referral



Name:	Wendy A. Woodward	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:	Radiation Therapy Oncology Group (RTOG)

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 study is to learn more about the side effects of partial breast re-irradiation given after a lumpectomy.

Study Objectives / Outcomes

Primary
To evaluate skin, breast, and chest wall adverse events occurring within 1 year from the
completion of reirradiation.

Secondary

To evaluate adverse events occurring after 1 year from the completion of re-irradiation and at any time.
To evaluate in-breast control rate.
To evaluate freedom from mastectomy rate.
To evaluate the rate of circulating tumor cells (CTCs) in this patient population and document eradication of CTCs by locoregional therapy.
Translational objective will correlate eradication or presence of CTCs with in-breast recurrence and distant metastasis free–survival.
To evaluate cosmesis as judged by the patient and independent evaluation.
To evaluate distant metastasis-free survival, mastectomy-free survival and overall survival.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	01/07/2011

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	61

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) Note: Per NCI Guidelines, Exceptions to Eligibility Are Not Permitted. Histopathologic confirmation via lumpectomy of local in-breast ipsilateral recurrence and final breast surgery (lumpectomy and/or final re-excision) within 42 days prior to study entry. Patients must have had an initial lumpectomy followed by whole breast radiation >1 year prior to study entry.

2) Histology of the local in-breast recurrence consistent with invasive ductal, medullary, tubular, mucinous, lobular; or ductal carcinoma in situ

3) Ipsilateral breast mammogram and MRI within 120 days prior to study entry. Contralateral breast mammogram within 12 months of study entry

4) Recurrent tumor size </= 3 cm in greatest dimension on pathologic specimen

5) Negative histologic margins of resection, no tumor on ink, following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins)

6) Estrogen/progesterone analysis performed prior to study entry

7) Axilla negative or </= 3 positive lymph nodes without extracapsular extension documented after evaluation

8) If invasive in-breast recurrence, whole body positron emission tomography - computed tomography (PET-CT) or all of the following: computed tomography (CT) of the chest, abdomen, pelvis and bone scan within 120 days prior to study entry (metastatic work-up not necessary for Ductal Carcinoma In-Situ Recurrences)

9) For females of childbearing potential, negative serum pregnancy test </= 7 days prior to study entry

10) History and physical exam performed within 120 days prior to study entry

11) Zubrod Performance status 0-1

12) Age >/= 18 years of age

13) The target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole breast reference volume must be <30% based on a postoperative, pretreatment CT scan

14) Patient must provide study specific informed consent prior to study entry.

Exclusion Criteria:

1) Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception

2) Women who are breast feeding

3) Evidence of multicentric ipsilateral breast recurrence or regional recurrence (other than axilla) documented by diagnostic mammography, breast ultrasound (optional), and/or breast MRI in invasive recurrences. Suspicious regions must be histologically proven negative to be eligible

4) Evidence of simultaneous distant recurrence documented by physical exam or radiographic evaluation in invasive recurrences

5) Clinical or radiographic evidence of metastatic disease in invasive recurrences

6) Patients with skin involvement

7) Prior invasive malignancy other than previous ipsilateral breast cancer and/or non-melanoma skin cancer unless disease free for a minimum of 3 years

8) Contralateral mastectomy

9) >3 positive axillary lymph nodes and/or metastatic axillary disease with extracapsular extension documented after evaluation

10) Patients with Paget's disease of the nipple

11) Patients with a breast technically unsatisfactory for partial breast irradiation.

12) Chemotherapy administered < 2 weeks prior to study entry and failing to recover from nonhematologic side effects </= grade 1

13) Patients with collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis

14) Patients with psychiatric or addictive disorders that would preclude obtaining informed consent

Links

Registration Number: NCT01082211
Study Information on Clinical Trials Registry (clinicaltrials.gov)