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S9927 Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Stage II Breast Cancer

This study has been terminated.
(due to lack of accrual)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
American College of Surgeons
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00005983
First received: July 5, 2000
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.


Condition Intervention Phase
Breast Cancer
 Radiation: radiation therapy
Procedure: surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Enrollment: 98
Study Start Date: June 2000
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: surgery
surgery followed by observation
 Procedure: surgery
surgery
Other Name: surgery
Experimental: surgery followed by RT
Surgery followed by radiation therapy
 Radiation: radiation therapy Procedure: surgery
surgery
Other Name: surgery

Detailed Description:

OBJECTIVES:

  • Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy and/or hormonal therapy.
  • Compare local regional control in patients treated with these regimens.
  • Assess the potential toxic effects of radiotherapy in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two treatment arms.

  • Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks.
  • Arm II: Patients are observed for disease progression. Patients are followed every 6 months for 2 years and then annually for 15 years.

PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for this study within 5 years.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage II adenocarcinoma of the breast (T1-2, N1, M0)

    • Primary tumor no greater than 5 cm
    • At least 1 but no more than 3 positive axillary lymph nodes
    • Nodes cannot be positive solely by cytokeratin staining
    • No apocrine, adenocystic, or squamous cell carcinomas or sarcomas of the breast
    • No bilateral breast cancer
    • No active local regional disease

  • Must have undergone a modified radical mastectomy with a level I and II with or without a level III axillary dissection (at least 10 nodes examined) within the past 8 months

    • Surgical margins negative for invasive and noninvasive ductal carcinoma
    • No gross extracapsular disease or residual disease in the axilla
    • Microscopic extracapsular extension allowed
  • No mastectomy after local failure following lumpectomy
  • Must have received adjuvant chemotherapy and/or hormonal therapy after mastectomy

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 21 and over

Sex:

  • Female

Menopausal status:

  • Pre- or post-menopausal

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No serious medical or psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior trastuzumab (Herceptin)

Chemotherapy:

  • See Disease Characteristics
  • No more than 6 weeks since prior adjuvant chemotherapy
  • No other prior chemotherapy
  • Concurrent adjuvant chemotherapy allowed

Endocrine therapy:

  • See Disease Characteristics
  • Concurrent adjuvant hormonal therapy allowed

Radiotherapy:

  • No prior chest wall or nodal radiotherapy

Surgery:

  • See Disease Characteristics
  • Breast reconstruction allowed

Other:

  • Concurrent registration on another adjuvant chemotherapy or hormonal therapy study is allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005983

Locations
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
American College of Surgeons
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Study Chair: Lori J. Pierce, MD University of Michigan Cancer Center
Study Chair: Michael G. Haddock, MD Mayo Clinic
Study Chair: Stephen B. Edge, MD Roswell Park Cancer Institute
Study Chair: Eric A. Strom, MD, FACR M.D. Anderson Cancer Center
Study Chair: Lawrence J. Solin, MD, FACR Abramson Cancer Center of the University of Pennsylvania
Study Chair: Lawrence B. Marks, MD Duke University
Study Chair: Timothy J. Whelan, MD Margaret and Charles Juravinski Cancer Centre
Study Chair: Melvin Deutsch, MD UPMC Cancer Center at UPMC Presbyterian
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00005983     History of Changes
Other Study ID Numbers: CDR0000067971, U10CA032102, S9927, S9927, CAN-NCIC-MA25, CLB-49910, S9927, S9927, S9927, RTOG-9915
Study First Received: July 5, 2000
Last Updated: January 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage II breast cancer

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

ClinicalTrials.gov processed this record on May 16, 2013