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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014