NCT05318274

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Compare the effectiveness of hypofractionated radiotherapy (1 week) with standard treatment (3.1 weeks) in the local control of breast cancer treated with conservative surgery. SECONDARY OBJECTIVES: I. Identify the histological lineage of the tumor. II. Identify the degree of differentiation of tumor cells. III. Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry. IV. Measure the frequency of progression or recurrence. V. Identify the site of progression or recurrence. VI. Measure the frequency of toxicity in both groups. VII. Classify toxicity according to its severity. VIII. Classify toxicity according to chronological presentation, acute, subacute, or chronic. IX. Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale, Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23). X. Measure quality of life in both groups according to the Eastern Collaborative Oncology Group (ECOG) performance scale. XI. Measure 5-year survival. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: will receive radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast. ARM II: will receive radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients. After completion of treatments, patients will be followed: 2 weeks after final fraction, 6 weeks after final fraction, every 4 months for the next 5 years

Conditions

• Ductal Breast Carcinoma in Situ
• Invasive Breast Cancer
• Early-stage Breast Cancer
• Stage 0 Breast Cancer
• Stage I Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiotherapy	Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.

Timeline

• Start date: 2021-04-26
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2022-04-08
• Last updated: 2026-03-23

Locations

1 site across 1 country: Mexico