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A prospective phase II clinical study of early breast cancer treated with hypofractionated simultaneous integrated boost IMRT after breast conservative surgery

A prospective phase II clinical study of early breast cancer treated with hypofractionated simultaneous integrated boost IMRT after breast conservative surgery

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016287
Enrollment
Unknown
Registered
2018-05-24
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-05-28

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

Conditions

early stage breast cancer after breast conservative surgery

Interventions

case series:hypofractionated simultaneous integrated boost intensity-modulated radiotherapy (IMRT)

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Women with 18-70 years of age; 2. Tis, T1-2N0M0 early breast cancer patients after breast conserving surgery according to the 2002 Union for International Cancer Control (UICC) staging standard; 3. pathology confirmed as invasive ductal carcinoma or ductal carcinoma in situ; 4. margin negative; 5. tumor beds marked with metal clip or clear postoperative serum swelling; 6. physical state (Eastern cooperativeOncology Group, ECOG) score 0-1.

Exclusion criteria

Exclusion criteria: 1. neoadjuvant chemotherapy before surgery; 2. margin positive; 3. bilateral breast cancer; 4. no radiotherapy in four months after surgery if the patient does not need adjuvant chemotherapy,or no radiotherapy in six months after surgery if the patient need adjuvant chemotherapy; 5. regional lymph nodes need irradiation; 6. multifocal lesions; 7. distant metastasis; 8. serious cardiopulmonary diseases, mental illness and body dysfunction; 9. history of tumor and (or) history of chest radiation; 10. male breast cancer; 11. contralateral breast cancer; 12. CT simulation can not clearly display the tumor cavity or the metal clips; 13. tumor bed volume / the whole breast volume >30%.

Design outcomes

Primary

MeasureTime frame
Breast cancer recurrence;local control rate;

Secondary

MeasureTime frame
overall survival rate;

Countries

China

Contacts

Public ContactWang Jie

Sichuan Cancer Hospital

wxr792000@163.com+86 18908178720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026