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Phase I/II study of different fractionation regimens of adjuvant radiation therapy in breast cancer patients after modified radical mastectomy

Phase I/II study of different fractionation regimens of adjuvant radiation therapy in breast cancer patients after modified radical mastectomy

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-14004391
Enrollment
Unknown
Registered
2014-03-09
Start date
2009-05-01
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

1:42.6Gy/16F adjuvant irradiation
2:36.5Gy/16F adjuvant irradiation

Sponsors

Department of Radiation Oncology, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Voluntary patients with written informed consent; (2) aged 18 to 75 years old; (3) undergoing modified radical mastectomy, and postoperative pathological diagnosis is invasive ductal carcinoma; (4) routine blood tests and liver and kidney functions are normal; (5) Karnofksy performance score more than 70; Life expectancy longer than 6 months; (6) without distant metastasis; (7) normal function of heart and lung.

Exclusion criteria

Exclusion criteria: (1) Distant metastasis; (2) With history of chest irradiation; (3) Active connective tissue diseases in treatment region; (4) Severe basic diseases: hypertension, cardiovascular disease, history of mental disease or allergy; (5) Refuse or unable to write informed consent; (6) Life expectancy shorter than 6 months.

Design outcomes

Primary

MeasureTime frame
Acute toxicities;Late toxicities;Loco-regional control;

Secondary

MeasureTime frame
Distant metastasis;

Countries

China

Contacts

Public ContactLin Ma

Department of Radiation Oncology, Chinese PLA General Hospital

malinpharm@sina.com+86 13911197589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026