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Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
intensity-modulated radiation therapy
Sponsored by
Institute of Cancer Research, United Kingdom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer

    • Resectable, unilateral disease
    • T1-3, N0-1, M0 disease
  • Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer

  • Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:

    • Age 18-49 years
    • Tumor size > 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)
    • Tumor of any size treated by primary medical therapy
    • Grade III disease
    • Minimum microscopic margin of noncancerous tissue < 5 mm (excluding deep margin if at deep fascia)
    • Lymphovascular invasion
    • Axillary node positive
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior mastectomy
  • No concurrent chemotherapy except primary or sequential chemotherapy

Sites / Locations

  • Royal Marsden - SurreyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Arm I (control)

Arm II

Arm III

Arm Description

Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).

Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).

Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).

Outcomes

Primary Outcome Measures

Palpable induration inside the boost volume of the irradiated breast

Secondary Outcome Measures

Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires)
Local tumor control
Location of tumor relapse in breast
Contralateral primary tumors
Regional and distant metastases
Overall survival

Full Information

First Posted
January 6, 2009
Last Updated
January 6, 2011
Sponsor
Institute of Cancer Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT00818051
Brief Title
Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer
Official Title
Randomized Trial Testing Dose Escalated Intensity Modulated Radiotherapy for Women Treated by Breast Conservation Surgery and Appropriate Systemic Therapy for Early Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Cancer Research, United Kingdom

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which radiation therapy schedule is more effective in treating breast cancer. PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.
Detailed Description
OBJECTIVES: To test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence. OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms. Arm I (control): Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy). Arm II: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy). Arm III: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy). Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years. Blood samples are collected at baseline and periodically thereafter. Tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor. After completion of study treatment, patients are followed annually for 10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (control)
Arm Type
Active Comparator
Arm Description
Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
Arm Title
Arm III
Arm Type
Experimental
Arm Description
Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Intervention Description
Given as 48, 53, or 56 Gy
Primary Outcome Measure Information:
Title
Palpable induration inside the boost volume of the irradiated breast
Secondary Outcome Measure Information:
Title
Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires)
Title
Local tumor control
Title
Location of tumor relapse in breast
Title
Contralateral primary tumors
Title
Regional and distant metastases
Title
Overall survival

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed invasive breast cancer Resectable, unilateral disease T1-3, N0-1, M0 disease Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following: Age 18-49 years Tumor size > 2.0 cm after primary surgery (maximum microscopic diameter of invasive component) Tumor of any size treated by primary medical therapy Grade III disease Minimum microscopic margin of noncancerous tissue < 5 mm (excluding deep margin if at deep fascia) Lymphovascular invasion Axillary node positive Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior mastectomy No concurrent chemotherapy except primary or sequential chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Yarnold, MD, FRCR
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John R. Yarnold, MD, FRCR
Phone
44-20-8661-3388

12. IPD Sharing Statement

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Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer

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