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

This study has suspended participant recruitment.
(The recuiting was to slow to complete the study)
Sponsor:
Information provided by (Responsible Party):
Shu lian Wang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00805597
First received: December 8, 2008
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Radiation: radiation
Radiation: no radiation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • loco-regional recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2008
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiotherapy
radiotherapy of 50Gy/25/f/5w to the ipsilateral chest wall and supraclavicular region
 Radiation: radiation
radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
Active Comparator: no radiotherapy
no radiotherapy
 Radiation: no radiation
no radiotherapy

Detailed 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.

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805597

Locations
China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Study Chair: Ye-xiong Li, M.D. Cancer Hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Shu lian Wang, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00805597     History of Changes
Other Study ID Numbers: LC2008B06
Study First Received: December 8, 2008
Last Updated: February 13, 2012
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:
breast cancer
mastectomy
one to three positive nodes
radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013