Know Cancer

or
forgot password

After Mapping Of The Axilla: Radiotherapy Or Surgery


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

Thank you

Trial Information

After Mapping Of The Axilla: Radiotherapy Or Surgery


OBJECTIVES:

- Compare the regional control of the axilla obtained by complete axillary lymph node
dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable
invasive breast cancer.

- Determine whether local and regional axillary control can be obtained without axillary
lymph node dissection in sentinel lymph node-negative women.

- Compare the axillary 5-year recurrence-free survival of these patients treated with
these regimens.

- Compare the morbidity of patients treated with these regimens.

- Compare the quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and type of breast surgery (conservation vs total mastectomy). Patients
are randomized to 1 of 2 treatment arms.

Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later
to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients
undergo wide local excision of the tumor or mastectomy after the sentinel node is removed.
If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo
complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel
node-negative patients receive no further treatment. Sentinel node-positive patients
continue treatment according to randomization.

- Arm I: Within 8 weeks after surgery, patients undergo complete ALND.

- Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy
daily 5 days a week for 5 weeks.

Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are
positive and more than 1 axillary level is involved.

Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years.

Patients are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091
sentinel node-negative) will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and
cytology) confirmed operable invasive breast cancer

- T0-2, N0

- Diagnosis by excisional tumorectomy allowed

- Clinically occult invasive disease must be histologically confirmed

- Only 1 tumor in 1 breast

- Tumor between 5 and 50 mm in largest diameter, within 1 quadrant by mammogram,
ultrasound or MRI

- Multifocal (i.e., within one quadrant and sharing the same histological
characteristics) is allowed

- Multicentric (i.e., in different quadrants) breast cancer is not allowed

- Clinically negative axillary lymph nodes

- No metastatic disease

- No previous treatment of the primary breast tumor by neoadjuvant hormonal or systemic
treatment

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- Any age

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or
axillary radiotherapy

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance

- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the
cervix

- Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to axilla

Surgery:

- No prior surgery to axilla

Other:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Axillary recurrence rate

Outcome Time Frame:

from randomization

Safety Issue:

No

Principal Investigator

Emiel JT Rutgers

Investigator Role:

Study Chair

Investigator Affiliation:

The Netherlands Cancer Institute

Authority:

United States: Federal Government

Study ID:

EORTC-10981-22023

NCT ID:

NCT00014612

Start Date:

February 2001

Completion Date:

Related Keywords:

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

Name

Location