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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Palpable induration inside the boost volume of the irradiated breast

Safety Issue:

No

Principal Investigator

John R. Yarnold, MD, FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

Unspecified

Study ID:

CDR0000629770

NCT ID:

NCT00818051

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

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