Trial record 2 of 1479 for:
breast,cancer,treatment | Open Studies
Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer
This study is currently recruiting participants.
Verified December 2012 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01127373
First received: May 19, 2010
Last updated: December 13, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2013 |
| Estimated Primary Completion Date: | May 2013 (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:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127373
Contacts
| Contact: Alice Ho, MD | 212-639-6773 | |
| Contact: Simon Powell, MD | 212-639-6072 |
Locations
| United States, New Jersey | |
| Memorial Sloan-Kettering at Basking Ridge | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Contact: Alice Ho, MD 212-639-6773 | |
| Contact: Simon Powell, MD 212-639-6072 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center @ Suffolk | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Alice Ho, MD 212-639-6773 | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Alice Ho, MD 212-639-6773 | |
| Memorial Sloan-Kettering at Mercy Medical Center | Recruiting |
| Rockville Centre, New York, United States | |
| Contact: Alice Ho, MD 212-639-6773 | |
| Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Recruiting |
| Sleepy Hollow, New York, United States, 10591 | |
| Contact: Alice Ho, MD 212-639-6773 | |
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 13, 2012 |
| 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 May 19, 2013