Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal… (NCT01266642) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
United States301 participantsStarted 2011-02-08
Plain-language summary
This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor cells. Giving higher doses of RT over a shorter period of time may kill more tumor cells and have fewer side effects. It is not yet known if hypofractionated RT is more effective than standard RT in treating breast cancer.
Who can participate
Age range40 Years
SexFEMALE
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Inclusion Criteria:
* Pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with ductal carcinoma in situ \[DCIS\] only); (upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy; for such patients, the criteria for pathologic stage shall be applied to the initial clinical stage)
* Treatment with breast conserving surgery
* Final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin; if the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a re-excision is strongly encouraged; lobular carcinoma in situ at the final surgical margin will be disregarded
* Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences.
* Female sex.
* Attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level I/II axilla with high tangents is allowed)
* If the patient has a history of a prior non-breast cancer, all treatm…
What they're measuring
1
Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis
Timeframe: 3 years after completing radiation therapy