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

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

radiation therapy

surgery

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Cancer Care Ontario-Hamilton Regional Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

surgery

surgery followed by RT

Arm Description

surgery followed by observation

Surgery followed by radiation therapy

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00005983

First Posted

July 5, 2000

Last Updated

January 22, 2013

Sponsor

SWOG Cancer Research Network

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

1. Study Identification

Unique Protocol Identification Number

NCT00005983

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Terminated

Why Stopped

due to lack of accrual

Study Start Date

June 2000 (undefined)

Primary Completion Date

March 2005 (Actual)

Study Completion Date

March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SWOG Cancer Research Network

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage II breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

surgery

Arm Type

Active Comparator

Arm Description

surgery followed by observation

Arm Title

surgery followed by RT

Arm Type

Experimental

Arm Description

Surgery followed by radiation therapy

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Type

Procedure

Intervention Name(s)

surgery

Intervention Description

surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials: