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| Sponsor: | Cancer Institute of New Jersey |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00909909 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: accelerated radiation therapy Radiation: hypofractionated radiation therapy Radiation: intensity-modulated radiation therapy Radiation: intracavitary balloon brachytherapy Radiation: whole breast irradiation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized |
| Official Title: | Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial |
| Estimated Enrollment: | 83 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.
Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.
After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer, including 1 of the following subtypes:
Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)
Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
No evidence of suspicious microcalcifications in the breast before the start of radiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Chemotherapy allowed provided the following criteria are met:
Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Principal Investigator: | Atif Khan, MD | Cancer Institute of New Jersey |
More Information
| Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Atif Khan ) |
| Study ID Numbers: | CDR0000643276, CINJ-040807 |
| Study First Received: | May 28, 2009 |
| Last Updated: | June 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00909909 History of Changes |
| Health Authority: | Unspecified |
|
ductal breast carcinoma in situ invasive ductal breast carcinoma invasive lobular breast carcinoma medullary ductal breast carcinoma with lymphocytic infiltrate mucinous ductal breast carcinoma |
papillary ductal breast carcinoma tubular ductal breast carcinoma stage I breast cancer stage II breast cancer stage IIIA breast cancer |
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Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |