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Prospective randomized controlled clinical trial of external beam radiotherapy + interstitial brachytherapy for breast cancer after breast-conserving surgery

Prospective randomized controlled clinical trial of external beam radiotherapy + interstitial brachytherapy for breast cancer after breast-conserving surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17010342
Enrollment
Unknown
Registered
2017-01-06
Start date
2017-02-01
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

Group B:external beam radiotherapy + interstitial brachytherapy

Sponsors

China-Japan Union Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 30 to 75 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 5 years,the other diease should consider; 3. 0 (DCIS),I, II (size=<3cm) stage breast cancer; 4. The patient has histologic confirmation of diagnosis of DCIS or invasive breast cancer; 5. The breast surgery is segment resection and negative of surgical margin, the first surgery is positive of surgery and secondary surgery is negative of surgical margin; 6. Axillary nodes is negative after axillary lymph node dissection; 7. The operation cavity of patient is clearly visible; 8. No radiotherapy contraindications.No hematopoietic function, heart, lung, liver, kidney dysfunction and immune deficiency; 9. 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 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 4cm; 6. Nipple Paget's disease; 7. Patients with a history of prosthesis implantation; 8. The patient has radiation therapy at the tumor region; 9. The patient has a serious concomitant medical condition including collagen vascular disease, idiopathic dermatomyositis, active cutaneous lupus, scleroderma, systemic lupus erythematosus; 10. Patient is pregnant or lactation woman; 11. Patient is mental disease or nervous system diseases; 12. The patient has participated in clinical studies of non-approved experimental agents or procedures within 4 weeks; 13. Failure to follow-up after treatment; 14.The data is missing or incomplete.

Design outcomes

Primary

MeasureTime frame
Breast cancer recurrence;Local control rate;Normal tissue side effects;Local beauty effect;Longterm survival;Quality of life;

Countries

China

Contacts

Public ContactCheng Guanghui

China-Japan Union Hospital of Jilin University

chengghcjuh@sina.com+86 13504334509

Outcome results

None listed

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