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

Phase 2 Study of Whole Breast Irradiation With Inversely Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: IMRT with an simultaneous integrated boost

• Study Type: Interventional
• Enrollment (Anticipated): 190
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhaozhi Yang, MD; Phone Number: 6601 862164175590; Email: yzzhi2006@yahoo.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • The Department of Radiation Oncology,Fudan University Cancer Hospital
      • Principal Investigator: Jiayi Chen, MD
      • Contact: Zhaozhi Yang, MD; Phone Number: 6601 862164175590; Email: yzzhi2006@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiation toxicity	first analysis will occur 2 year after accrual of all patients
Cosmetic outcome	first analysis will occur 2 year after accrual of all patients

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to ipsilateral breast recurrence	first analysis will occur 5 year after accrual of all patients
Local recurrence rate	first analysis will occur 5 year after accrual of all patients
Disease free survival	first analysis will occur 5 year after accrual of all patients
Overall survival	first analysis will occur 5 year after accrual of all patients

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jiayi Chen, MD, The Department of Radiation Oncology, Fudan University Cancer Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 13, 2011
• First Posted (Estimate): July 14, 2011

Study Record Updates

• Last Update Posted (Estimate): March 27, 2013
• Last Update Submitted That Met QC Criteria: March 26, 2013
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: breast cancer; radiotherapy; IMRT; simultaneous integrated boost; tumor bed
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BR-RT-001