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

This study has been terminated.
(The recuiting was to slow to complete the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00805597
First Posted: December 9, 2008
Last Update Posted: August 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shu lian Wang, Chinese Academy of Medical Sciences
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Shu lian Wang, Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • overall survival [ Time Frame: 10 years ]

Secondary Outcome Measures:
  • loco-regional recurrence [ Time Frame: 5 years ]

Enrollment: 40
Study Start Date: June 2008
Study Completion Date: February 2012
Primary Completion Date: February 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Responsible Party: Shu lian Wang, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00805597     History of Changes
Other Study ID Numbers: LC2008B06
First Submitted: December 8, 2008
First Posted: December 9, 2008
Last Update Posted: August 8, 2016
Last Verified: August 2016

Keywords provided by Shu lian Wang, 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