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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

IMRT with an simultaneous integrated boost

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, radiotherapy, simultaneous integrated boost, tumor bed, IMRT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The Department of Radiation Oncology,Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT-SIB

Arm Description

Outcomes

Primary Outcome Measures

Radiation toxicity

Cosmetic outcome

Secondary Outcome Measures

Time to ipsilateral breast recurrence

Local recurrence rate

Disease free survival

Overall survival

Full Information

NCT ID

NCT01394575

First Posted

July 13, 2011

Last Updated

March 26, 2013

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01394575

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

July 2013 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IMRT-SIB

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

IMRT with an simultaneous integrated boost

Intervention Description

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

Primary Outcome Measure Information:

Title

Radiation toxicity

Time Frame

first analysis will occur 2 year after accrual of all patients

Title

Cosmetic outcome

Time Frame

first analysis will occur 2 year after accrual of all patients

Secondary Outcome Measure Information:

Title

Time to ipsilateral breast recurrence

Time Frame

first analysis will occur 5 year after accrual of all patients

Title

Local recurrence rate

Time Frame

first analysis will occur 5 year after accrual of all patients

Title

Disease free survival

Time Frame

first analysis will occur 5 year after accrual of all patients

Title

Overall survival

Time Frame

first analysis will occur 5 year after accrual of all patients

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhaozhi Yang, MD

Phone

862164175590

Ext

6601

yzzhi2006@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiayi Chen, MD

Organizational Affiliation

The Department of Radiation Oncology, Fudan University Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Department of Radiation Oncology,Fudan University Cancer Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhaozhi Yang, MD

Phone

862164175590

Ext

6601

yzzhi2006@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Jiayi Chen, MD

12. IPD Sharing Statement

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

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