N/A
Completed N=116
Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer
Source: ClinicalTrials.gov NCT01127373 ↗Enrolled (actual)
116
Serious AEs
8.6%
Results posted
Apr 2021
Primary outcomePrimary: Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification — 1; 111; 4 Participants
Summary
This study is being performed to understand the safety of a new radiation treatment called "Multi-Beam Intensity Modulated Radiation Therapy" ( IMRT). Currently, the standard way of giving radiation is with "simplified" IMRT, which uses only 2 beams of radiation. "Multi-beam" IMRT works by using 6-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the breast, chest wall, and the lymph nodes. At the same time, multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered, especially when the internal mammary lymph nodes need to be targeted by radiation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification |
1; 111; 4 | — |
| SECONDARY Number of Participants Evaluated for Acute and Late Cutaneous Toxicity |
116 | — |
| SECONDARY Number of Participants Evaluated for Late Subcutaneous Fibrosis |
1; 115 | — |
| SECONDARY Mean FEV1 at Baseline |
2.6 | — |
| SECONDARY Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) |
79.6 | — |
| SECONDARY Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg) |
18.8 | — |
| SECONDARY Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score |
83.2 | — |
| SECONDARY Median Follow-up Period |
53.4 | — |
Eligibility Criteria
Inclusion Criteria
- Female gender
- Age ≥18 years
- An invasive primary breast cancer of any histology arising from breast parenchyma
- Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection
- Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is ≥1 and M stage is 0.
- Patient signed study-specific consent form.
Exclusion Criteria
- Patients with distant metastasis.
- Patients who are pregnant or breastfeeding.
- Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
- Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months.
- Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist.
- Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
- Primary breast cancer is a lymphoma or sarcoma histology.
- Patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer.
- Patients requiring radiation to the bilateral breasts.
Data sourced from ClinicalTrials.gov (NCT01127373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.