⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for 3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer

Official Title: Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.

Study ID: NCT00802711

Conditions

Breast Cancer

Study Description

Brief Summary: RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal 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. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer. PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with stage I or stage II breast cancer.

Detailed Description: OBJECTIVES: Primary * To compare the rate of successfully delivered accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial brachytherapy in women with stage I or II invasive ductal carcinoma of the breast. * To establish potential patient participation in ongoing phase III clinical trials (e.g., NSABP-B-39, GEC-ESTRO, RAPID, MPORT, and IRMA) that compare APBI to standard whole-breast irradiation. Secondary * To assess acute radiation-induced toxicity in these patients as assessed by NCI CTCAE version 3.0. * To assess long-term radiation-induced toxicity in these patients as assessed by RTOG-EORTC scale. * To assess the incidence and type of adverse events in the breast of these patients. * To assess the incidence and type of procedure-related complications in these patients. * To determine local control and pattern of recurrence in these patients. * To determine disease-free survival (distant and recurrence-free survival) of these patients. * To determine overall survival of these patients. * To assess cosmesis in these patients as assessed by the Breast Cancer Treatment Outcome and RTOG scales. * To assess treatment-related symptoms in these patients as assessed by the Breast Cancer Treatment Outcome scale. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with a lumpectomy cavity/whole breast ratio 25-30% are assigned to treatment in arm II. * Arm I: Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. Patients complete quality-of-life questionnaires at baseline, on the last day of treatment, at 4 and 24 weeks after completion of treatment, and then annually for 3 years. After completion of study treatment, patients are followed periodically for at least 5 years.

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Saint Luke's Radiation Oncology Network, Dublin, , Ireland

Contact Details

Name: Pierre Thirion, MD

Affiliation: Saint Luke's Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: