NCT00068263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
11.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

December 1, 2016

Enrollment Period

1.8 years

First QC Date

September 10, 2003

Last Update Submit

December 30, 2016

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancer

Interventions

radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1) * Unifocal disease (single focus that can be encompassed by one lumpectomy) * The following histologies are eligible: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (4)

  • 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.

    PMID: 19910132RESULT

  • 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.

    PMID: 16198508RESULT

  • 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.

    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.

    PMID: 23726000DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Frank Vicini, MD, FACR

    William Beaumont Hospital - Royal Oak Campus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

August 1, 2003

Primary Completion

June 1, 2005

Study Completion

December 1, 2016

Last Updated

January 4, 2017

Record last verified: 2016-12

Locations

US(2)