NCT00084539

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells. PURPOSE: This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

June 10, 2004

Last Update Submit

March 1, 2016

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerbreast cancer in situ

Outcome Measures

Primary Outcomes (1)

  • Acute toxicity by CTCAE at 6 weeks

    6 weeks

Secondary Outcomes (1)

  • Quality of life as measured by the Breast Cancer Treatment Outcome Scale (BCTOS) every 6 months for 5 years

    every 6 months for 5 years

Study Arms (1)

Radiation therapy

EXPERIMENTAL

Radiation Therapy Daily 5 days per week for 4 weeks 45 Gy in 20 fractions whole breast 56 Gy in 20 fractions to boost volume

Radiation: Radiation therapy

Interventions

Radiation therapyRADIATION
Radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed carcinoma of the breast * Invasive or in-situ disease * Stage Tis, T1, or T2 (AJCC stage 0, I, or II) disease * Treated with breast-conserving surgery within the past 8 weeks * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * Not specified Renal * Not specified Other * No other malignancy within the past 2 years except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer * No active systemic lupus * No history of scleroderma * No other medical or psychiatric condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 6 weeks since prior adjuvant systemic chemotherapy * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the breast Surgery * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Carcinoma In Situ

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Penny Anderson, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

November 1, 2003

Primary Completion

November 1, 2005

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

US(1)