Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

Randomized Trial Testing Dose Escalated Intensity Modulated Radiotherapy for Women Treated by Breast Conservation Surgery and Appropriate Systemic Therapy for Early Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00818051
• Other study ID #: CDR0000629770
• Secondary ID: ICR-IMPORT-HIGHI
• Status: Recruiting
• Phase: Phase 3
• First received: January 6, 2009
• Last updated: January 6, 2011
• Start date: August 2008

Study information

• Verified date: January 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which radiation therapy schedule is more effective in treating breast cancer.

PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.

Description:

OBJECTIVES:

• To test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence.

OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.

• Arm I (control): Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).

• Arm II: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).

• Arm III: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).

Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years. Blood samples are collected at baseline and periodically thereafter. Tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor.

After completion of study treatment, patients are followed annually for 10 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Resectable, unilateral disease

• T1-3, N0-1, M0 disease

• Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer

• Requires a tumor bed boost plus whole breast radiotherapy as indicated by = 1 of the following:

• Age 18-49 years

• Tumor size > 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)

• Tumor of any size treated by primary medical therapy

• Grade III disease

• Minimum microscopic margin of noncancerous tissue < 5 mm (excluding deep margin if at deep fascia)

• Lymphovascular invasion

• Axillary node positive

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior mastectomy

• No concurrent chemotherapy except primary or sequential chemotherapy

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• intensity-modulated radiation therapy
Given as 48, 53, or 56 Gy

Locations

Country	Name	City	State
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palpable induration inside the boost volume of the irradiated breast			No
Secondary	Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires)			Yes
Secondary	Local tumor control			No
Secondary	Location of tumor relapse in breast			No
Secondary	Contralateral primary tumors			No
Secondary	Regional and distant metastases			No
Secondary	Overall survival			No