Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00002873
First received: November 1, 1999
Last updated: July 17, 2013
Last verified: February 2008
  Purpose

RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who have stage I or stage II breast cancer.


Condition Intervention Phase
Breast Cancer
Radiation: brachytherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A PHASE I/II TRIAL TO EVALUATE BRACHYTHERAPY AS THE SOLE METHOD OF RADIATION THERAPY FOR STAGE I AND II BREAST CARCINOMA

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Study Start Date: May 1997
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the technical feasibility and reproducibility, cosmetic results, complication rates, and local cancer control rate experience with brachytherapy used as the sole method of radiotherapy in women with stage I/II breast cancer treated with tylectomy who have histologically assessed negative surgical margins, less than 4 positive axillary nodes, and no extracapsular nodal extension or extensive intraductal component. II. Reduce the total treatment time of breast irradiation from 6 weeks to 4-5 days in these patients.

OUTLINE: Treatment begins no sooner than 4 days and within 6 weeks after definitive surgery. All patients receive brachytherapy to the target volume (as defined by the excision cavity demarcated by post-tylectomy surgical clips plus 2 cm margin) using iridium-192 implants for dose distribution to five planes. Patients may be treated with either high-dose-rate or low-dose-rate brachytherapy at the institution's discretion. Patients are followed at 2 and 6 weeks after treatment, then at 3, 6, 9 and 12 months, then every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 46 patients will be accrued in each group (high-dose rate vs low-dose rate) over 2 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed nonlobular invasive breast cancer of one of the following histologies: Ductal Papillary Medullary Colloid (mucinous) Tubular Stage I/II (T1-2 N0-1 M0) tumor no greater than 3 cm Prior tylectomy and axillary lymph node dissection required No more than 3 positive axillary lymph nodes and no extracapsular extension At least 6 lymph nodes sampled OR Negative sentinal node Surgical clips in place delineating margins of tylectomy cavity Negative, or close but negative, inked histologic margins of tylectomy or re-excision specimen Negative margins defined as no tumor at least 2 mm away from the inked margins Close but negative margins defined as tumor within 2 mm of inked margin Positive margins defined as invasive or noninvasive tumor at inked resection margins Negative post-tylectomy or post-reexcision mammogram required if disease presented with malignancy-associated microcalcifications No remaining suspicious microcalcifications If catheters are placed at time of reexcision, the crieria may not be feasible but a post brachytherapy mammogram should be obtained as soon as possible No extensive intraductal carcinoma by the Harvard definition, i.e.: More than 25% of tumor is ductal carcinoma in situ (DCIS) and there is DCIS in adjacent breast tissue OR Intraductal carcinoma with microinvasion No proven multicentric carcinoma, i.e.: Tumor in different quadrants of the breast OR Tumor separated by at least 4 cm The following exclude: Skin or chest wall invasion Matted or fixed axillary adenopathy Metastatic internal mammary or supraclavicular nodes Paget's disease of the nipple Previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No collagen vascular disease with a c-reactive protein level above normal or with an active skin rash (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis) No coexisting medical condition that reduces life expectancy to less than 2 years No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for breast cancer Planned chemotherapy may begin at least 2 weeks after removal of brachytherapy catheters Endocrine therapy: Concurrent tamoxifen permitted Radiotherapy: No prior radiotherapy for breast cancer Surgery: See Disease Characteristics

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002873

  Show 232 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Robert R. Kuske, MD Ochsner Cancer Institute at Ochsner Clinic Foundation
  More Information

Additional Information:
Publications:
Rabinovitch R, Winter K, Taylor M, et al.: Toxicity and cosmesis from RTOG 95-17: a phase I/II trial to evaluate brachytherapy as the sole method of radiation therapy for stage I and II breast carcinoma. [Abstract] Breast Cancer Res Treat 106 (1): A-4078, S192-3, 2007.
Arthur DW, Winter K, Kuske RR, et al.: A phase II trial of brachytherapy alone following lumpectomy for select breast cancer: tumor control and survival outcomes of RTOG 95-17. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-51, S29-30, 2006.
Kuske RR, Winter K, Arthur DW, et al.: A phase II trial of brachytherapy alone following lumpectomy for stage I or II breast cancer: initial outcomes of RTOG 9517. [Abstract] J Clin Oncol 22 (Suppl 14): A-565, 18s, 2004.
Kuske RR, Winter K, Arthur D, et al.: A phase I/II trial of brachytherapy alone following lumpectomy for select breast cancer: toxicity analysis of Radiation Therapy Oncology Group 95-17. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-151, 87, 2002.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00002873     History of Changes
Other Study ID Numbers: RTOG-9517, CDR0000065157
Study First Received: November 1, 1999
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage I breast cancer
stage II breast cancer
medullary ductal breast carcinoma with lymphocytic infiltrate
mucinous ductal breast carcinoma
invasive ductal breast carcinoma
papillary ductal breast carcinoma
tubular ductal breast carcinoma

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

ClinicalTrials.gov processed this record on October 23, 2014