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

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ClinicalTrials.gov Identifier: NCT00005983
Recruitment Status : Terminated (due to lack of accrual)
First Posted : January 27, 2003
Last Update Posted : January 24, 2013
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
NSABP Foundation Inc
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Radiation: radiation therapy Procedure: surgery Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2000
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: surgery
surgery followed by observation
Procedure: surgery
surgery

Experimental: surgery followed by RT
Surgery followed by radiation therapy
Radiation: radiation therapy
Procedure: surgery
surgery





Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
NSABP Foundation Inc
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

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00005983     History of Changes
Other Study ID Numbers: CDR0000067971
U10CA032102 ( U.S. NIH Grant/Contract )
S9927 ( Other Identifier: SWOG )
S9927 ( Other Identifier: ACOSOG )
CAN-NCIC-MA25 ( Other Identifier: NCIC-CTG )
CLB-49910 ( Other Identifier: CALGB )
S9927 ( Other Identifier: ECOG )
S9927 ( Other Identifier: NCCTG )
S9927 ( Other Identifier: NSABP )
RTOG-9915 ( Other Identifier: RTOG )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Southwest Oncology Group:
stage II breast cancer

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