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Spots Global Cancer Trial Database for Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer

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Trial Identification

Brief Title: Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer

Official Title: Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer

Study ID: NCT00084539

Conditions

Breast Cancer

Interventions

Radiation therapy

Study Description

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.

Detailed Description: OBJECTIVES: Primary * Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer. Secondary * Determine the long-term cosmetic result and quality of life of patients treated with this regimen. * Determine the long-term local control in patients treated with this regimen. OUTLINE: Patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks. Quality of life is assessed within 1 month of starting radiotherapy, at 6 weeks after completion of radiotherapy, and then every 6 months for 5 years. Patients are followed at 6 weeks and then every six months for 5 years. PROJECTED ACCRUAL: A total of 37-74 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Contact Details

Name: Penny Anderson, MD

Affiliation: Fox Chase Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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