Skip to main content
OpenTrials
Completed

NCT Number: NCT00084539

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Primary outcomes

  1. Acute toxicity by CTCAE at 6 weeks

    Time frame: 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer

Important dates

Study start
2003
Primary completion
2005
First posted
Jun 11, 2004
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.