Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01127373
First received: May 19, 2010
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Radiation: Multi-Beam Intensity-Modulated Radiation Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To assess the feasibility of adjuvant radiation therapy via multi-beam IMRT using daily 3D position verification [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the rate and severity of both acute and late cutaneous toxicity [ Time Frame: 5-7 months following the completion of radiation therapy ] [ Designated as safety issue: Yes ]
  • To evaluate the rate and severity of late subcutaneous fibrosis [ Time Frame: 5-7 months following the completion of radiation therapy ] [ Designated as safety issue: No ]
  • To evaluate the rate and severity of radiation pneumonitis (RP) [ Time Frame: 5-7 months following the completion of radiation therapy ] [ Designated as safety issue: No ]
  • To evaluate local-regional control rates [ Time Frame: 5-7 months following the completion of radiation therapy ] [ Designated as safety issue: No ]
  • To evaluate patient set-up reproducibility in breast cancer patients treated with multi-beam IMRT [ Time Frame: 5-7 months following the completion of radiation therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiation therapy via multi-beam IMRT
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Radiation: Multi-Beam Intensity-Modulated Radiation Therapy
IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
Other Names:
  • BreastQ questionnaire- The BreastQ questionnaires have been developed by the
  • MSKCC Department of Surgery. For patients who received a mastectomy with or
  • without reconstruction, the questionnaire will be administered at baseline and
  • 5-7 months after treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127373

Locations
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States, 10591
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Alice Ho, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01127373     History of Changes
Other Study ID Numbers: 10-025
Study First Received: May 19, 2010
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast
Radiation
Multi-Beam Intensity-Modulated Radiation
post mastectomy
post partial mastectomy
node-positive breast cancer
10-025

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014