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Multicenter, randomized, parallel-group phase III clinical studies of accelerated partial-breast irradiation versus whole-breast irradiation after breast-conserving surgery of early breast cancer

Multicenter, randomized, parallel-group phase III clinical studies of accelerated partial-breast irradiation versus whole-breast irradiation after breast-conserving surgery of early breast cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003827
Enrollment
Unknown
Registered
2013-11-05
Start date
2013-12-02
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Breast cancer

Interventions

Treatment group:Partial-breast irradiation
Control group:Whole-breast irradiation

Sponsors

Gansu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 35 to 70 years, the patient's ECOG performance status is 0 to 2, or KPS score is more than 70; 2. The patient's life expectancy is greater than five years,the other diease should consider 3. 0 (DCIS),I, II (size==4.0*10^9/L, absolute neutrophil count>=2.0*10^9/L, platelet count>=100*10^9/L, hemoglobin count=100g/L; 12. The patient is capable of understanding and complying with the protocol and has signed the informed consent document.

Exclusion criteria

Exclusion criteria: 1. Male breast cancer; 2. III, IV(size>=3?)stage breast cancer; 3. Suspected patients is not confirm by pathology; 4. Non epithelial malignant tumors, for example, sarcoma or lymphoma; 5. Multicenter tumor in more than one quadrant in breast or single lesion is more than 4?; 6. Bilateral breast cancer; 7. Patients with a history of breast cancer; 8. The surgery is not negative of surgical margin; 9. The operation cavity of patient is not clearly visible; 10. The patient has prosthesis implantation in breast; 11. The patient has radiation therapy at the tumor region; 12. The patient has a serious concomitant medical condition including collagen vascular disease, idiopathic dermatomyositis, active cutaneous lupus, scleroderma, systemic lupus erythematosus; 13. Patient is pregnant or nursing woman; 14. Patient is mental disease,nervous system diseases and did not describe the treatment effect 15. The patient has participated in clinical studies of non-approved experimental agents or procedures within 4 weeks; 16. The patient is unwilling to comply with study procedures, as specified by this protocol, or is unwilling to cooperate fully with the investigator.

Design outcomes

Primary

MeasureTime frame
Breast cancer recurrence;Local control rate;

Secondary

MeasureTime frame
overall survival;recurrence free survival;distant metastasis free survival;quality of life;Boood routine test;Liver function test;renal function test;electrolyte test;

Countries

China

Contacts

Public ContactXiaohu Wang

Gansu Cancer Hospital

xhwanggansu@163.com+86 13909407551

Outcome results

None listed

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