A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-Risk Breast Cancer - Full Text View

Sponsored by:	Chinese Academy of Medical Sciences
Information provided by:	Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00793962

Purpose

The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.

Condition	Intervention	Phase
Breast Cancer	Radiation: hypofractionation radiotherapy Radiation: conventional fractionation radiotherapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-Risk Breast Cancer

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:

locoregional control rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1072
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region	Radiation: hypofractionation radiotherapy radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
2: Active Comparator conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region	Radiation: conventional fractionation radiotherapy 50Gy/25/f/5w

Detailed Description:

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region.

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ipsilateral histologically confirmed invasive breast cancer
Undergone total mastectomy and axillary dissection
T3-4,or axillary lymph nodes positive
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793962

Contacts

Contact: shu-lian wang, M.D.

8610-87788122

wsl20040118@yahoo.com

Locations

China
Cancer Hospital, Chinese Academy of Medical Sciences	Recruiting
Beijing, China, 100021
Principal Investigator: shu-lian wang, M.D.

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

Principal Investigator:

shu-lian wang, M.D.

Cancer Hospital, Chinese Academy of Medical Sciences

More Information

Responsible Party:	Cancer Hospital, Chinese Academy of Medical Sciences ( Cancer Hospital, Chinese Academy of Medical Sciences )
Study ID Numbers:	LC2008A06
Study First Received:	November 17, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00793962
Health Authority:	China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:

breast cancer
mastectomy
radiotherapy
fractionation

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009