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Radiation Therapy in Treating Women With Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00814567
First received: December 24, 2008
Last updated: January 6, 2011
Last verified: December 2008
History of Changes
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer.

PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating women with early-stage breast cancer who have undergone breast-conservation surgery.


Condition Intervention Phase
Breast Cancer
 Radiation: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Location of tumor relapse [ Designated as safety issue: No ]
  • Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment [ Designated as safety issue: No ]
  • Regional and distant metastases [ Designated as safety issue: No ]
  • Late adverse effects in normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments [ Designated as safety issue: Yes ]
  • Quality of life as assessed by EORTC QLQ C-30, EORTC QLQ-BR23, BIS, and HADS questionnaires in a subset of patients at baseline, 6 months, and 1, 2, and 5 years [ Designated as safety issue: No ]
  • Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years [ Designated as safety issue: No ]

Estimated Enrollment: 1935
Study Start Date: October 2006
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (control)
Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.
 Radiation: radiation therapy
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
Experimental: Arm II
Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
 Radiation: radiation therapy
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
Experimental: Arm III
Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
 Radiation: radiation therapy
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy

Detailed Description:

OBJECTIVES:

  • To test partial breast radiotherapy using intensity-modulated techniques following complete local tumor excision in women with low-risk, early stage breast cancer.

OUTLINE: This is a multicenter study.

Patients are stratified according to center (not participating in sub-studies vs participating in sub-studies). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (control): Patients undergo standard whole breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.
  • Arm II: Patients undergo reduced whole breast radiotherapy (15 fractions) and standard partial breast radiotherapy (15 fractions) once daily on days 1-5 for 3 weeks.
  • Arm III: Patients undergo standard partial breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.

All patients complete a family history questionnaire at baseline. Patients also undergo blood sample collection at baseline and paraffin-embedded tissue collection at follow-up for molecular studies analyzing inter-patient variation by microarrays.

Patients in centers participating in sub-studies undergo quality of life and health economic assessment at baseline, 6 months, and 1, 2, and 5 years. These patients also undergo photographic assessment at baseline, 2 years, and 5 years.

After completion of study treatment, patients are followed for 10 years.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of low-risk early stage breast cancer, meeting the following criteria:

    • Invasive adenocarcinoma

      • No invasive carcinoma of classical lobular type
      • No lymphovascular invasion
    • Tumor size pathologically determined to be ≤ 3.0 cm in diameter (pT1-2) (< 3.1 cm maximum microscopic diameter of invasive component)
    • Unifocal disease
    • Grade I, II, or III disease

    • Axillary lymph nodes negative (pN0)

      • Sentinel lymph node biopsy and isolated tumor cells < 0.2 mm allowed

  • Must have undergone breast conservation surgery with or without adjuvant systemic therapy

    • Minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
  • At low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence)
  • No prior mastectomy
  • No blood-borne metastases

PATIENT CHARACTERISTICS:

  • No prior malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior endocrine therapy or chemotherapy

    • Neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met
    • No primary endocrine therapy as a replacement for surgery
  • No concurrent chemoradiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814567

Locations
United Kingdom
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: John R. Yarnold, MD, FRCR     44-20-8661-3388        
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Principal Investigator: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
  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

ClinicalTrials.gov Identifier: NCT00814567     History of Changes
Other Study ID Numbers: CDR0000629768, ICR-IMPORT-LOW, ICR-CTSU/2006/10001, ISRCTN12852634, EU-20896
Study First Received: December 24, 2008
Last Updated: January 6, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IA breast cancer
stage II breast cancer
invasive ductal breast carcinoma
invasive ductal breast carcinoma with predominant intraductal component

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

ClinicalTrials.gov processed this record on May 21, 2013