Partial Breast Irradiation for Low-risk Ductal Carcinoma... | NCT02617082

Studies
Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery

NCT02617082

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Nov 30, 2015Estimated

Enrollment

828Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

partial breast irradiation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2019Estimated

Completion Date

Not provided

First Submitted Date

Nov 21, 2015

First Submission Date that Met QC Criteria

Nov 27, 2015

First Posted Date

Nov 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2015

Last Update Posted Date

Nov 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Detailed Description

Randomized clinical trials have demonstrated that the recurrence of DCIS is low and most of the recurrence occurs around the tumor bed. Besides, cosmetic outcomes are reported better in partial breast irradiation group compared to whole breast irradiation group. However, whether or not partial breast irradiation is safety in DCIS is still unknown. The purpose of this study is to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

828Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
partial breast irradiation			Radiation: partial breast irradiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
partial breast irradiation	Radiation	The prescription dose is 40.5Gy in 15 fractions in 3 weeks.	partial breast irradiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ipsilateral breast tumor recurrence		5 years

Secondary Outcomes

Measure	Description	Time Frame
occurrence of contralateral breast tumor after PBI		5 years
Disease free survival		5 years
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
18~65 years old
Pathologically confirmed DCIS, low- or intermediate- grade DCIS: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade DCIS: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3)
Treated with breast conserving surgery
Tumor bed is labeled with Titanium clips
No malignancy history
ECOG score 0~1
Written informed consent

Exclusion Criteria:

DCIS of both breast
invasive breast cancer
Multicentric disease
Patients underwent mastectomy
Previous radiation therapy of breast
Medical contraindication for radiotherapy
Pregnant or nursing
suspicious calcification after surgery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

DCIS breast cancer patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaoli Yu, MD.PhD	Contact	+86 18017312388		stephanieyxl@hotmail.com
Zhaozhi Yang, MD.PhD	Contact	+86 18017317126		yzzhi2014@163.com

Overall Officials

Name	Affiliation	Role
Xiaoli Yu, MD.PhD	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center	Recruiting	Shanghai	Shanghai Municipality	200032	China

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D002285	Carcinoma, Intraductal, Noninfiltrating

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

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Browse Branches

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