RecruitingNot ApplicableNCT05318274

Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.

Hypofractionated Radiation Therapy (1 Week) Compared With Standard Treatment (3.1 Weeks), Evaluation of Local Control of Breast Cancer Treated With Conservative Surgery.


Sponsor

Coordinación de Investigación en Salud, Mexico

Enrollment

72 participants

Start Date

Apr 26, 2021

Study Type

INTERVENTIONAL

Summary

An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • Patients diagnosed by histopathological report of ductal carcinoma in situ (DCIS) or invasive breast carcinoma.
  • Treated with breast-conserving surgery and stage pT1-2 pN0 M0.
  • Over 18 years.
  • Patients who sign informed consent for research study.

Exclusion Criteria4

  • Positive nodes.
  • Clinical or pathological stage T3-T4.
  • History of previous irradiation.
  • Postoperative positive margin.

Interventions

RADIATIONHypofractionated radiotherapy

Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.


Locations(1)

Unidad Medica de Alta Especialidad

Mérida, Yucatán, Mexico

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NCT05318274