Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Terminated

Phase 3

Conditions

Breast Cancer

Treatments

Radiation: radiation

Radiation: no radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT00805597

LC2008B06

Details and patient eligibility

About

The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.

Full description

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and no radiotherapy.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Enrollment

40 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ipsilateral histologically confirmed invasive breast cancer
Undergone total mastectomy and axillary dissection
T1-2 and one to three axillary lymph nodes positive
A minimum of 10 axillary nodes dissected
Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
Written,informed consent

Exclusion criteria

Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
Previous or concurrent malignant other than non-melanomatous skin cancer
Unable or unwilling to give informed consent