Whole Breast Irradiation With Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients (IMRT-SIB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01394575
First received: July 13, 2011
Last updated: March 26, 2013
Last verified: June 2011
  Purpose

This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma in situ treated by breast conserving surgery, postoperative whole breast irradiation with inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic outcome and local control rate in a single center


Condition Intervention Phase
Breast Cancer
Radiation: IMRT with an simultaneous integrated boost
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Whole Breast Irradiation With Inversely Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Radiation toxicity [ Time Frame: first analysis will occur 2 year after accrual of all patients ] [ Designated as safety issue: Yes ]
  • Cosmetic outcome [ Time Frame: first analysis will occur 2 year after accrual of all patients ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to ipsilateral breast recurrence [ Time Frame: first analysis will occur 5 year after accrual of all patients ] [ Designated as safety issue: No ]
  • Local recurrence rate [ Time Frame: first analysis will occur 5 year after accrual of all patients ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: first analysis will occur 5 year after accrual of all patients ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: first analysis will occur 5 year after accrual of all patients ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT-SIB Radiation: IMRT with an simultaneous integrated boost
IMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group performance score﹤2
  • All patients aged >18 years and < 70 years after breast conserving surgery.
  • On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
  • Negative nodal status determined by sentinel node biopsy, or axillary dissection. Axillary staging is not required for patients with DCIS
  • No evidence of distant metastasis
  • Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins(>2mm)
  • Surgical treatment of the breast must have been lumpectomy. Re-excision of surgical margins is permitted.
  • The patient must consent to be in the study and must have signed an approved consent form.

Exclusion Criteria:

  • Eastern Cooperative Oncology Group performance score≧2
  • Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
  • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant of separated.
  • Metastatic disease (M1)
  • Pregnancy or lactating
  • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
  • Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
  • Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Prior breast or thoracic RT for any condition.
  • Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
  • Synchronous chemotherapy or target therapy is not permitted.
  • Refusal of the patients to be included in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394575

Contacts
Contact: Zhaozhi Yang, MD 862164175590 ext 6601 yzzhi2006@yahoo.com.cn

Locations
China, Shanghai
The Department of Radiation Oncology,Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhaozhi Yang, MD    862164175590 ext 6601    yzzhi2006@yahoo.com.cn   
Principal Investigator: Jiayi Chen, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jiayi Chen, MD The Department of Radiation Oncology, Fudan University Cancer Hospital
  More Information

No publications provided

Responsible Party: The Department of Radiation Oncology, Fudan University Cancer Hospital, Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT01394575     History of Changes
Other Study ID Numbers: BR-RT-001
Study First Received: July 13, 2011
Last Updated: March 26, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
breast cancer
radiotherapy
simultaneous integrated boost
tumor bed
IMRT

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

ClinicalTrials.gov processed this record on April 17, 2014