Skip to content

A III Phase Study of Postmastectomy Hypofractionated Radiotherapy in Breast Cancer

A III Phase Study of Postmastectomy Hypofractionated Radiotherapy in Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042855
Enrollment
Unknown
Registered
2021-01-30
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-17

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:Nil
50Gy/25F group:Nil

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The subjects who voluntarily participated and signed the informed consent in writing; 2. Female, aged 18-70 years; 3. Patients with stage IIA (excluding T2N0) - IIIc breast cancer were pathologically invasive; 4. Patients after modified radical operation; 5. Patients receiving chemotherapy, endocrine therapy or targeted therapy as planned; 6. Patients with axillary lymph node metastasis diagnosed by pathology, and invasive cancer patients with modified radical operation after neoadjuvant chemotherapy; 7. Subjects with normal blood routine, liver and kidney function; 8. Patients with Karnofsky score >= 80 had an expected survival period of more than 12 months; 9. Subjects without serious underlying diseases of heart and lung.

Exclusion criteria

Exclusion criteria: 1. Patients whose operation time is more than 8 months from the beginning of adjuvant radiotherapy; 2. HER-2 positive patients without targeted therapy; 3. Patients who did not complete postoperative adjuvant chemotherapy as planned; 4. Er / PR positive patients without postoperative adjuvant endocrine therapy; 5. Patients with distant metastasis; 6. Patients with previous radiotherapy history in the area to be irradiated; 7. Patients with active connective tissue disease in the treatment area; 8. Patients with severe comorbidities and psychiatric history; 9. Patients who refused or could not sign the informed consent to participate in the trial; 10. Patients with expected survival less than 12 months.

Design outcomes

Primary

MeasureTime frame
locoregional relapse;

Secondary

MeasureTime frame
overal survival;disease-free survial;acute side effects;late side effects;

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