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Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the feasibility of adjuvant radiation therapy via multi-beam IMRT using daily 3D position verification

Outcome Time Frame:

5 weeks

Safety Issue:

No

Principal Investigator

Alice Ho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-025

NCT ID:

NCT01127373

Start Date:

May 2010

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Breast
  • Radiation
  • Multi-Beam Intensity-Modulated Radiation
  • post mastectomy
  • post partial mastectomy
  • node-positive breast cancer
  • 10-025
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York