Clinical Trial of Postmastectomy Radiotherapy in Breast C... | NCT00805597

Studies
Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

NCT00805597

Sponsor

Chinese Academy of Medical Sciences

Status

Terminated

Last Update Posted

Aug 8, 2016Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Breast Cancer

Interventions

radiation
no radiation

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The recuiting was to slow to complete the study

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Dec 8, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

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

Aug 4, 2016

Last Update Posted Date

Aug 8, 2016Estimated

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

The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.

Detailed Description

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and no radiotherapy.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
radiotherapy	Experimental	radiotherapy of 50Gy/25/f/5w to the ipsilateral chest wall and supraclavicular region	Radiation: radiation
no radiotherapy	Active Comparator	no radiotherapy	Radiation: no radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiation	Radiation	radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region	radiotherapy

Measure	Description	Time Frame
overall survival		10 years

Measure	Description	Time Frame
loco-regional recurrence		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ipsilateral histologically confirmed invasive breast cancer
Undergone total mastectomy and axillary dissection
T1-2 and one to three axillary lymph nodes positive
A minimum of 10 axillary nodes dissected
Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
Written,informed consent

Exclusion Criteria:

Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
Previous or concurrent malignant other than non-melanomatous skin cancer
Unable or unwilling to give informed consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ye-xiong Li, M.D.	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital, Chinese Academy of Medical Sciences		Beijing		100021	China

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided