A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

This study is currently recruiting participants.
Verified January 2014 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Shu lian Wang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00793962
First received: November 17, 2008
Last updated: January 28, 2014
Last verified: January 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

Resource links provided by NLM:


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 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hypofractionation radiotherapy
breast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy 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
Other Name: radiotherapy
Active Comparator: conventional fractionation radiotherapy
breast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
Radiation: conventional fractionation radiotherapy
50Gy/25/f/5w
Other Name: radiotherapy

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 >=4 positive axillary lymph nodes
  • Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
  • Written,informed consent
  • cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy
  • no supraclavicular or internal mammary nodes metastases
  • no distant metastases
  • enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy.
  • enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.

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
  • bilateral breast cancer
  • immediate or delayed ipsilateral breast cancer reconstruction
  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
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: NCT00793962     History of Changes
Other Study ID Numbers: LC2008A06
Study First Received: November 17, 2008
Last Updated: January 28, 2014
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:
breast cancer
mastectomy
radiotherapy
fractionation

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

ClinicalTrials.gov processed this record on April 15, 2014