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A phase I~II study on hypofractionated radiation therapy after conservative surgery in breast cancer patients.

A phase I~II study on hypofractionated radiation therapy after conservative surgery in breast cancer patients.

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039754
Enrollment
Unknown
Registered
2020-11-08
Start date
2020-11-30
Completion date
Unknown
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

36.5Gy/10F group:hypofractionated radiotherapy (10F)
42.5Gy/16F group:hypofractionated radiotherapy (16F)

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged from 18 to 75 years old; 2. Female; 3. Patients conventionally recieve adjuvant chemotherapy after conservative surgery(neo-chemotherapy is permitted); 4. Histopathology examination shows invasive carcinoma; 5. TNM stging :pT1-2 pN0-1 M0; 6. KPS >= 70 or ECOC 0-1; 7. Patients are supposed to survive over 5 years at least; 8. Simultaneous endocrine therapy and targeted therapy for HER-2 are permitted; 9. Patients voluntarily participate in study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Controlateral breast cancer as well as DCIS are not allowed, no matter when diagnosed; 2. Systematic metastasis exist; 3. The regional area planed to be received radiotherapy had a history of irradiation; 4. Patients failed to completed adjuvant chemotherapy and/or targeted therapy as schedule; 5. Active connective tissue disease involved in the treatment area; 6. Patients with severe complications,such as hypertension, coronary heart disease,mental disease or patients who have a history of severe allergy.

Design outcomes

Primary

MeasureTime frame
acute side effects;late side effects;

Secondary

MeasureTime frame
outcomes;

Countries

China

Contacts

Public ContactLin Ma

Department of Radiation Oncology, First Medical Center of Chinese PLA General Hospital

malinpharm@sina.com+86 13911197589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026