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Phase I/II clinical trial of definitely carbon ion therapy for breast cancer

Phase I/II clinical trial of definitely carbon ion therapy for breast cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067648
Enrollment
Unknown
Registered
2023-01-16
Start date
2023-01-16
Completion date
Unknown
Last updated
2023-05-15

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:CIRT

Sponsors

Wuwei Tumor Hospital Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18; 2. Pathological diagnosis of primary breast tumor; 3. Patients with UICC version 8 cT1-3N1-2M0; 4. Patients unwilling or unable to operate; 5. No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer); 6. Good physical condition, that is, ECOG 0~2; 7. Expected life >= 6 months; 8. Before radiotherapy, the patient or its legal representative has signed the informed consent form.

Exclusion criteria

Exclusion criteria: Patients with any one or more of the following exclusion criteria will not be selected for inclusion: 1. Patients who cannot lie down quietly for 30 minutes; 2. The distance between tumor and skin is less than 5mm; 3. Weight loss of more than 20% within six months; 4. Pregnancy (via serum or urine ß- HCG test) or during lactation; 5. Drug abuse or alcohol dependence; 6. AIDS patients; 7. Accompanied with uncontrolled systemic, pulmonary or heart disease; 8. Accompanied with serious complications that make the test program unable to proceed smoothly, including uncontrolled complications (pulmonary insufficiency, cardiovascular disease, lung, liver, kidney, diabetes, etc.), addiction and/or mental disease; Connective tissue diseases (such as scleroderma and systemic lupus) or the history of malignant tumors that may interfere with the treatment plan in the past were excluded. 9. The implantation of cardiac pacemaker or other metal prosthesis is enough to affect the radiotherapy; 10. Patients with poor compliance, including those who may not be able to complete the treatment plan or cannot accept the prescribed follow-up and examination; 11. Have suffered from other malignant tumors (except cured skin cancer and stage 0 cervical cancer); 12. Serum creatinine clearance rate < 30ml/min; 13. There are contraindications to radiotherapy; 14. Participated in clinical trials of other drugs within 30 days before joining this trial; 15. No civil capacity or limited civil capacity; 16. Any medical history, according to the investigator's judgment, may interfere with the test results or increase the patient's risk; 17. Any circumstance that the physician thinks is not suitable to participate in the test; 18. The patient refused to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
OS;

Secondary

MeasureTime frame
PFS;adverse reaction;Local control rate;

Countries

China

Contacts

Public ContactYanshan Zhang

Wuwei Tumor Hospital Heavy Ion Center

13830510999@163.com+86 138 3051 0999

Outcome results

None listed

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