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A II Phase Study of Postmastectomy Hypo-fractionated Radiotherapy Combined with Immediate Two-Stage Prosthetic Breast Reconstruction in Breast Cancer

A II Phase Study of Postmastectomy Hypo-fractionated Radiotherapy Combined with Immediate Two-Stage Prosthetic Breast Reconstruction in Breast Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058621
Enrollment
Unknown
Registered
2022-04-12
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

breast cancer

Interventions

42.5Gy/16F:radiation
36.5Gy/10F:radiation

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. Participate voluntarily and sign the informed consent in writing; 2. Female, aged 18-70; 3. All patients underwent mastectomy, and the postoperative pathology was invasive carcinoma; 4. Immediately implant a dilator after glandular resection; 5. Normal blood routine test, liver and kidney function; 6. There is no serious underlying disease in the heart and lungs.

Exclusion criteria

Exclusion criteria: 1. Patients whose breast gland resection is more than 8 months away from the start of adjuvant radiotherapy; 2. HER-2 positive patients without targeted treatment; 3. Patients who did not complete postoperative adjuvant chemotherapy as planned; 4. Patients with ER/PR positive and without postoperative adjuvant endocrine therapy; 5. Patients with distant metastasis; 6. The area to be irradiated has a history of previous radiotherapy; 7. Patients with active connective tissue disease in the treatment area; 8. Patients with serious complications; 9. Patients with an estimated survival period of less than 12 months.

Design outcomes

Primary

MeasureTime frame
Cellulitis;hematoma;subcutaneous hematoma;effusion;skin flap necrosis;

Secondary

MeasureTime frame
locoregional relapse;overal survival;

Countries

China

Contacts

Public ContactLin Ma

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