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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute toxicity by CTCAE at 6 weeks

Safety Issue:

Yes

Principal Investigator

Penny Anderson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000365456

NCT ID:

NCT00084539

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • breast cancer in situ
  • Breast Neoplasms

Name

Location
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111