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Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00084539
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : March 3, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Radiation therapy Phase 2

Detailed Description:



  • Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer.


  • Determine the long-term cosmetic result and quality of life of patients treated with this regimen.
  • Determine the long-term local control in patients treated with this regimen.

OUTLINE: Patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks.

Quality of life is assessed within 1 month of starting radiotherapy, at 6 weeks after completion of radiotherapy, and then every 6 months for 5 years.

Patients are followed at 6 weeks and then every six months for 5 years.

PROJECTED ACCRUAL: A total of 37-74 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer
Study Start Date : November 2003
Actual Primary Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Radiation therapy

Radiation Therapy

Daily 5 days per week for 4 weeks

45 Gy in 20 fractions whole breast

56 Gy in 20 fractions to boost volume

Radiation: Radiation therapy

Primary Outcome Measures :
  1. Acute toxicity by CTCAE at 6 weeks [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Quality of life as measured by the Breast Cancer Treatment Outcome Scale (BCTOS) every 6 months for 5 years [ Time Frame: every 6 months for 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed carcinoma of the breast

    • Invasive or in-situ disease
    • Stage Tis, T1, or T2 (AJCC stage 0, I, or II) disease
  • Treated with breast-conserving surgery within the past 8 weeks
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Not specified

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3


  • Not specified


  • Not specified


  • No other malignancy within the past 2 years except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer
  • No active systemic lupus
  • No history of scleroderma
  • No other medical or psychiatric condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • No more than 6 weeks since prior adjuvant systemic chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy to the breast


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00084539

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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Penny Anderson, MD Fox Chase Cancer Center

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Responsible Party: Fox Chase Cancer Center Identifier: NCT00084539     History of Changes
Other Study ID Numbers: CDR0000365456
P30CA006927 ( U.S. NIH Grant/Contract )
03026 ( Other Identifier: Fox Chase Cancer Center )
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016
Keywords provided by Fox Chase Cancer Center:
stage I breast cancer
stage II breast cancer
breast cancer in situ
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases