Whole Breast Irradiation With Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients

Breast Cancer Clinical Trial

— IMRT-SIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01394575
• Other study ID #: BR-RT-001
• Status: Recruiting
• Phase: Phase 2
• First received: July 13, 2011
• Last updated: March 26, 2013
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: June 2011
• Source: Fudan University
• Contact: Zhaozhi Yang, MD
• Phone: 862164175590
• Email: yzzhi2006[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• IMRT with an simultaneous integrated boost
IMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed

Locations

Country	Name	City	State
China	The Department of Radiation Oncology,Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation toxicity		first analysis will occur 2 year after accrual of all patients	Yes
Primary	Cosmetic outcome		first analysis will occur 2 year after accrual of all patients	No
Secondary	Time to ipsilateral breast recurrence		first analysis will occur 5 year after accrual of all patients	No
Secondary	Local recurrence rate		first analysis will occur 5 year after accrual of all patients	No
Secondary	Disease free survival		first analysis will occur 5 year after accrual of all patients	No
Secondary	Overall survival		first analysis will occur 5 year after accrual of all patients	No