NCT00818051

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
Last Updated

January 7, 2011

Status Verified

January 1, 2009

First QC Date

January 6, 2009

Last Update Submit

January 6, 2011

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

  • Palpable induration inside the boost volume of the irradiated breast

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Arm I (control)

ACTIVE COMPARATOR

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

Radiation: intensity-modulated radiation therapy

Arm II

EXPERIMENTAL

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

Radiation: intensity-modulated radiation therapy

Arm III

EXPERIMENTAL

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

Radiation: intensity-modulated radiation therapy

Interventions

intensity-modulated radiation therapyRADIATION

Given as 48, 53, or 56 Gy

Arm I (control)Arm IIArm III

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • John R. Yarnold, MD, FRCR

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

August 1, 2008

Last Updated

January 7, 2011

Record last verified: 2009-01

Locations

GB(1)