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

NCT01394575 | Unknown Phase 2

• 1 other identifier: BR-RT-001
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer

Keywords

breast cancer; radiotherapy; simultaneous integrated boost; tumor bed; IMRT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

IMRT-SIB

EXPERIMENTAL

Radiation: IMRT with an simultaneous integrated boost

Interventions

IMRT with an simultaneous integrated boost RADIATION

IMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed

IMRT-SIB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

The Department of Radiation Oncology,Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Jiayi Chen, MD

  The Department of Radiation Oncology, Fudan University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaozhi Yang, MD

CONTACT

862164175590; yzzhi2006@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 14, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 27, 2013

Record last verified: 2011-06

Locations

CN (1)