A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID: NCT00581256
Run by: University of Michigan Rogel Cancer Center
People needed: 54
Starts: 2006-04-01
Expected to finish: 2016-04-01
Last updated by the study team: 2017-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 ECOG 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.

You may not qualify if…

Patients who are pregnant or are nursing are excluded.
Pathologically node negative breast cancer unless treated with neo-adjuvant chemotherapy.
Performance status > 2 by ECOG 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.

Where it is running

University of Michigan Health Systems — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.