3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection

NCT ID: NCT00068263

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2016-12-31

Brief Summary

RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.

Detailed Description

OBJECTIVES:

• Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy confined to the region of the lumpectomy cavity in women with stage I or II breast cancer.
• Determine the cosmetic results in patients treated with this regimen.
• Determine the complication rates in patients treated with this regimen.
• Determine the local control rate in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery.

Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to 15.3 months.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Invasive ductal
• Medullary
• Papillary
• Colloid (mucinous)
• Tubular
• No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (DCIS)
• No nonepithelial breast malignancies such as sarcoma or lymphoma
• Previously treated with lumpectomy of a lesion no greater than 3 cm and axillary dissection of at least 6 lymph nodes or a sentinel node biopsy

• Six surgical clips in place delineating the margins of the tylectomy cavity
• Negative, inked histologic margins of lumpectomy (greater than 2 mm) OR re-excision specimen available for confirmation
• Negative mammography post-lumpectomy or post-excision if malignancy-associated microcalcifications were initially present
• No prior lumpectomy so extensive that the cosmetic result is low or poor prior to radiotherapy
• No more than 3 positive axillary nodes
• No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless negative by biopsy
• No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless nodes are histologically negative
• No extensive intraductal carcinoma, indicated by one of the following according to the Harvard definition:

• More than 25 % of invasive tumor is DCIS and DCIS is in adjacent breast tissue
• Intraductal carcinoma with microinvasion
• No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
• No evidence of suspicious microcalcifications
• No Paget's disease of the nipple
• No skin involvement by disease, regardless of tumor size
• No distant metastases
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• At least 2 years

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Technically suitable for breast radiotherapy
• No collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis)
• No other medical condition that would limit life expectancy
• No psychiatric or addictive disorders that would preclude giving informed consent
• No other malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 2 weeks since prior chemotherapy
• No concurrent chemotherapy during and for at least 2 weeks after completion of study therapy

Endocrine therapy

• Concurrent anastrozole or tamoxifen allowed

Radiotherapy

• No prior radiotherapy for the current malignancy

Surgery

• See Disease Characteristics

Other

• No prior nonhormonal therapy for the current malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NRG Oncology

OTHER

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Vicini, MD, FACR

Role: STUDY_CHAIR

William Beaumont Hospital - Royal Oak Campus

Locations

Foundation for Cancer Research and Education

Phoenix, Arizona, United States

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

Countries

United States

References

Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.

Reference Type: RESULT

PMID: 19910132 (View on PubMed)

Vicini F, Winter K, Straube W, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, McCormick B. A phase I/II trial to evaluate three-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for Stage I/II breast carcinoma: initial report of feasibility and reproducibility of Radiation Therapy Oncology Group (RTOG) Study 0319. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1531-7. doi: 10.1016/j.ijrobp.2005.06.024. Epub 2005 Sep 29.

Reference Type: RESULT

PMID: 16198508 (View on PubMed)

Vicini F, Winter K, Straube W, et al.: A phase I/II trial to evaluate three dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma: initial report of feasibility and reproducibility of Radiation Therapy Oncology Group (RTOG) study 0319. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-4067, 2004.

Reference Type: RESULT

Chafe S, Moughan J, McCormick B, Wong J, Pass H, Rabinovitch R, Arthur DW, Petersen I, White J, Vicini FA. Late toxicity and patient self-assessment of breast appearance/satisfaction on RTOG 0319: a phase 2 trial of 3-dimensional conformal radiation therapy-accelerated partial breast irradiation following lumpectomy for stages I and II breast cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):854-9. doi: 10.1016/j.ijrobp.2013.04.005. Epub 2013 May 29.

Reference Type: DERIVED

PMID: 23726000 (View on PubMed)

Other Identifiers

CDR0000316246

Identifier Type: -

Identifier Source: secondary_id

RTOG-0319

Identifier Type: -

Identifier Source: org_study_id