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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00084539
First received: June 10, 2004
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Breast Cancer
Radiation: Radiation therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Acute toxicity by CTCAE at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: November 2003
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Not specified

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

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

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the breast

Surgery

  • See Disease Characteristics
  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: NCT00084539

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Penny Anderson, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00084539     History of Changes
Other Study ID Numbers: CDR0000365456, P30CA006927, 03026
Study First Received: June 10, 2004
Last Updated: August 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
stage I breast cancer
stage II breast cancer
breast cancer in situ

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

ClinicalTrials.gov processed this record on July 24, 2014