Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NSABP Foundation Inc
Radiation Therapy Oncology Group
Southwest Oncology Group
Trans-Tasman Radiation Oncology Group (TROG)
North Central Cancer Treatment Group
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00005957
First received: July 5, 2000
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.


Condition Intervention Phase
Breast Cancer
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Regional Radiation Therapy in Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 13 years ] [ Designated as safety issue: No ]
    Duration of study


Secondary Outcome Measures:
  • Disease-free survival (including locoregional and distant disease) [ Time Frame: 13 years ] [ Designated as safety issue: No ]
    Duration of study

  • Toxicity assessed by NCI CTC v2.0 [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
    Baseline, last week of radiation treatment, months 3 and 9 after last dose of radiotherapy, then every 6 months for 2 years and then annually.

  • Quality of life assessed by the EORTC QLQ-C30, OCOG Breast Cancer Questionnaire [ Time Frame: annually until distance recurrence ] [ Designated as safety issue: No ]
    Baseline, last week of radiation treatment, 3 and 9 months after last dose of radiotherapy than annually until distance recurrence.

  • Cosmetic outcome according to the EORTC Breast Cancer Rating System for Cosmetic Results of Breast Conserving Treatment [ Time Frame: 33 and 57 months ] [ Designated as safety issue: No ]
    Baseline at 33 months and 57 months post radiotherapy.


Enrollment: 1832
Study Start Date: April 2000
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Breast Irradiation Radiation: radiation therapy

Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.

Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.

Experimental: Breast Radiation plus regional radiation
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Radiation: radiation therapy

Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.

Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.


Detailed Description:

OBJECTIVES:

  • Compare the overall survival, disease-free survival, isolated local regional disease-free survival, and distant disease-free survival in women with previously resected, early stage, invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the quality of life of patients (in certain participating centers) treated with these regimens.
  • Compare the cosmetic outcomes in patients (in certain participating centers) treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), number of axillary nodes removed (<10, > or equal to 10); type of chemotherapy (anthracycline containing vs other vs none), hormonal therapy (yes vs no), number of axillary lymph nodes excised*, and participating center. Patients are randomized to one of two treatment arms.

NOTE: * Patients with a negative sentinel node dissection with or without an axillary dissection will be stratified according to the total number of nodes removed

  • Arm I: Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

Radiotherapy in both arms begins as soon as possible after randomization. Radiotherapy must begin within 8 weeks after completion of adjuvant IV chemotherapy, unless radiotherapy is administered concurrently with chemotherapy (i.e., cyclophosphamide, methotrexate, and fluorouracil [CMF]), or within 16 weeks after the last breast surgery for patients treated with hormonal therapy alone.

Quality of life is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 and 9 months after completion of radiotherapy, and then annually until first distant disease recurrence.

Cosmetic outcome is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, and then at 3 and 5 years after completion of radiotherapy or until first distant disease recurrence.

Patients are followed at 3, 6, and 9 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 1,822 patients will be accrued for this study within approximately 4 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven invasive carcinoma of the breast

    • No evidence of T4, N2-3, or M1 disease prior to surgery
    • Node positive or high-risk node negative
  • Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT

    • Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision
    • Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site
    • Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria

      • If node positive, then a level I and II axillary dissection must be performed
    • No evidence of residual disease in axilla after dissection
  • Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy
  • High risk of regional and systemic recurrence due to one of the following:

    • Pathologically positive axillary lymph nodes
    • Pathologically negative axillary lymph nodes with one of the following:

      • Primary tumor greater than 5 cm
      • Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:

        • Estrogen receptor negative
        • Skarf-Bloom-Richardson grade 3
        • Lymphovascular invasion
  • Hormone receptor status:

    • Estrogen and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Sex:

  • Female

Menopausal status:

  • Premenopausal or postmenopausal

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 5 years

Hematopoietic:

  • Not specified

Hepatic:

  • SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)*
  • Alkaline phosphatase no greater than 3 times ULN* NOTE: * Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations

Renal:

  • No serious nonmalignant renal disease

Cardiovascular:

  • No serious nonmalignant cardiovascular disease

Pulmonary:

  • No serious nonmalignant pulmonary disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy
  • No other malignancy except:

    • Nonmelanomatous skin cancer
    • Carcinoma in situ of the cervix or endometrium
    • Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast)
    • Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation
  • No psychiatric or addictive disorder that would preclude informed consent or study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • Concurrent standard adjuvant chemotherapy allowed

Endocrine therapy:

  • See Disease Characteristics
  • Concurrent standard adjuvant hormonal therapy allowed

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005957

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
The Vitalite Health Network - Dr. Leon Richard
Moncton, New Brunswick, Canada, E1C 8X3
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Canada, Nova Scotia
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6
Niagara Health System
St. Catharines, Ontario, Canada, L2R 7C6
Northeast Cancer Center Health Sciences
Sudbury, Ontario, Canada, P3E 5J1
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University - Dept. Oncology
Montreal, Quebec, Canada, H2W 1S6
CHUQ-Pavillon Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NCIC Clinical Trials Group
NSABP Foundation Inc
Radiation Therapy Oncology Group
Southwest Oncology Group
Trans-Tasman Radiation Oncology Group (TROG)
North Central Cancer Treatment Group
Investigators
Study Chair: Timothy J. Whelan, MD Margaret and Charles Juravinski Cancer Centre
Study Chair: David S. Parda Allegheny Cancer Center at Allegheny General Hospital
Study Chair: Julia R. White, MD Medical College of Wisconsin
Study Chair: Lori J. Pierce, MD University of Michigan Cancer Center
Study Chair: Boon Chua, MD Peter MacCallum Cancer Centre, Australia
Study Chair: Laura A. Vallow, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00005957     History of Changes
Other Study ID Numbers: MA20, CAN-NCIC-MA20, NSABP-CAN-NCIC-MA20, NCCTG-CAN-NCIC-MA20, RTOG-CAN-NCIC-MA20, SWOG-CAN-NCIC-MA20, TROG-CAN-NCIC-MA20, CDR0000067938
Study First Received: July 5, 2000
Last Updated: March 20, 2014
Health Authority: Canada: NCIC Clinical Trials Group

Keywords provided by NCIC Clinical Trials Group:
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014