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

Breast Cancer Clinical Trial

Official title:

A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00805597
• Other study ID #: LC2008B06
• Status: Terminated
• Phase: Phase 3
• First received: December 8, 2008
• Last updated: August 4, 2016
• Start date: June 2008
• Est. completion date: February 2012

Study information

• Verified date: August 2016
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• radiation
radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
• no radiation
no radiotherapy

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		10 years	No
Secondary	loco-regional recurrence		5 years	No