A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer - Full Text View

Sponsor:	University of Michigan Cancer Center
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00581256

Purpose

Radiotherapy has been shown to reduce breast-cancer specific mortality in patients at high risk for distant dissemination. It has also been shown to increase rates of non-breast cancer deaths and morbidity due to cardiovascular and pulmonary toxicity. Although treatment planning has improved significantly through the years, recent reports still demonstrate treatment-related morbidity even with 3-dimensional planned techniques. Thus, while 3D planning represents the state of the art treatment for loco-regional radiotherapy for breast cancer, further improvement is needed to continue to decrease heart and lung exposure. The ultimate goal of the proposed research is to determine whether treatment planning using intensity-modulated radiotherapy (IMRT), the "next generation" of radiation treatment delivery systems, results in less radiation exposure to the heart and lungs than the best current RT technique in women with node positive breast cancer. This proposal will test the potential clinical value of IMRT compared to the best standard 3D plan (partially wide tangent fields, PWTF) in the treatment of breast cancer. These two treatment techniques will be studied in a Phase II randomized trial using quantitative indicators of potential cardiac and lung toxicity. The preliminary data generated from this trial will be used to ultimately justify a multi-institutional comparison of the two treatment techniques with long-term clinical cardiac and pulmonary toxicity as endpoints.

Condition	Intervention	Phase
Breast Cancer	Radiation: IMRT Radiation: 3D	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:

To compare the extent of new myocardial perfusion defects following breast cancer radiotherapy using the best standard 3-D radiotherapy technique, partially wide tangent fields, versus the best optimized technique. [ Time Frame: approximately 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare changes in ejection fraction and alterations in cardiac wall motion with treatment by technique [ Time Frame: approx 1 year ] [ Designated as safety issue: Yes ]
To compare changes in lung perfusion defects and pulmonary function tests (DLCO, FEV1, and FVC) by technique [ Time Frame: approx 1 year ] [ Designated as safety issue: Yes ]
To compare rates of pericarditis and pneumonitis by technique [ Time Frame: approx 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Best Delivery-optimized radiotherapy technique (IMRT)	Radiation: IMRT All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume.
2: Active Comparator Best 3-dimensional standard PWTF technique	Radiation: 3D All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease

Arms

Assigned Interventions

1: Experimental

Best Delivery-optimized radiotherapy technique (IMRT)

Radiation: IMRT

All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume.

2: Active Comparator

Best 3-dimensional standard PWTF technique

Radiation: 3D

All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease

Detailed Description:

Primary Objective 1.1 To compare the extent of new myocardial perfusion defects following breast cancer radiotherapy using the best standard 3-D radiotherapy technique, partially wide tangent fields, versus the best optimized technique.
Secondary Objectives 2.1 To compare changes in ejection fraction and alterations in cardiac wall motion with treatment by technique 2.2 To compare changes in lung perfusion defects and pulmonary function tests (DLCO, FEV1, and FVC) by technique 2.3 To compare rates of pericarditis and pneumonitis by technique

Cardiac Endpoints: Myocardial SPECT-CT perfusion defects, ejection fraction, alterations in cardiac wall motion, per SPECT-CT (adenosine stress and rest (if necessary)) scan.

Pulmonary Endpoints: Lung SPECT-CT perfusion defects per SPECT-CT scan, and changes in pulmonary function tests: DLCO, FEV1, FVC Clinical Endpoints: pericarditis and pneumonitis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligibility Criteria

Breast cancer diagnosis: Patients must have histologically confirmed adenocarcinoma of the breast requiring comprehensive loco-regional irradiation that includes treatment to the intact breast/chest wall, supraclavicular (SCV), infraclavicular nodes (ICV), and internal mammary nodes (IMN).
Patients must have pathologic T 1, 2, 3 or 4, N 1, 2, or 3 Stage II or III disease as defined by the AJCC Staging System, 6th edition. Patients who do not undergo axillary staging but are at risk for nodal involvement may also be treated.
All patients must have left-sided breast cancer.
Both men and women are eligible.
Patients must be adults (18 years of age or older)
For women of child-bearing age, effective contraception must be used. A written statement must be obtained that the patient is not pregnant. If there is any question of pregnancy at time of therapeutic RT or at time of each SPECT-CT scan, a pregnancy test will be done to confirm the patient is not pregnant.
Performance status should be 0-2 by Southwest Oncology group criteria.
Patients that have received prior RT may be enrolled on the present study if the new breast lesion can be treated with no overlap of RT fields.
Patients must be aware of the neoplastic nature of her/his disease.
Patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with the Institutional Review Board (IRB) of the University of Michigan and federal guidelines.
Patients' blood tests should indicate they are able to tolerate radiotherapy. Tests must be done within 28 days of registration:

CBC with differential and platelet count (Hemoglobin > 8.0 g/dl; wbc > 2000/mm3; absolute neutrophil count > 1000/mm3; platelet count > 75,000/mm3.

Exclusion Criteria:

Patients who are pregnant or are nursing are excluded.
Pathologically node negative breast cancer unless treated with neo-adjuvant chemotherapy.
Performance status > 2 by Southwest Oncology Group criteria
Patients who are unable to lie on their back and raise their arm above their head in the treatment planning position for radiotherapy
Patients with a clinically unstable medical condition
Patients with a life-threatening disease state
History or suspicion of serious life-threatening allergic reaction to Tc-99m imaging agents.
Patients that have had breast-conservation surgery with positive margins or any patient with negative margins with a tumor positive for an extensive intraductal component.
Patients that are not able to use the ABC device.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581256

Contacts

Contact: Monika R Benedict-Blue, BSW

734-936-4596

shabla@umich.edu

Locations

United States, Michigan
University of Michigan Health Systems	Recruiting
Ann Arbor, Michigan, United States, 48109-5010
Principal Investigator: Lori J Pierce, MD.

Sponsors and Collaborators

University of Michigan Cancer Center

More Information

No publications provided

Responsible Party:	University of Michigan ( Dr Lori J. Pierce, MD )
Study ID Numbers:	UMCC 2004.038, IRB #2002-387
Study First Received:	December 20, 2007
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00581256 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:

left sided

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009