Status:
UNKNOWN
Radiation Therapy in Women With Low Risk Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborating Sponsors:
Cancer Research UK
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
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 intensi...
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 m...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of low-risk early stage breast cancer, meeting the following criteria:
- Invasive adenocarcinoma
- No invasive carcinoma of classical lobular type
- lympho-vascular invasion present or absent
- 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 or 1-3 nodes positive (pN0 or pN+(1-3))
- 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
Exclusion
Key Trial Info
Start Date :
May 3 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
2018 Patients enrolled
Trial Details
Trial ID
NCT00814567
Start Date
May 3 2007
End Date
September 1 2020
Last Update
February 27 2019
Active Locations (1)
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1
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT