Feasibility Study of Stereotactic Body Radiotherapy for E... | NCT02065960

Studies
Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer

NCT02065960

Sponsor

Juravinski Cancer Center

Status

Unknown status

Last Update Posted

Mar 31, 2015Estimated

Enrollment

32Estimated

Phase

Phase 1

Conditions

Breast Neoplasm

Interventions

Stereotactic body radiotherapy (SBRT)

Countries

Canada

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

Mar 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

Feb 2014

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Feb 12, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 19, 2014Estimated

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

Mar 30, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julie Arsenault, MD, FRCPC, Clinical Research Fellow, Radiation Oncology, Juravinski Cancer CenterPrincipal Investigator

Lead Sponsor

Juravinski Cancer CenterOTHER

Collaborators

Name	Class
Juravinski Cancer Centre Foundation	OTHER
Canadian Breast Cancer Foundation	OTHER

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

Most women with early breast cancer are treated with breast conserving therapy (BCT), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. This treatment can take time and is associated with its own side effect profile. An innovative radiation technique called stereotactic body radiotherapy (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been successfully used for a number of cancers and it is proposed that it could be used to eradicate breast cancer. This feasibility study will investigate the feasibility and safety of treatment using SBRT in women with early stage breast cancer.

Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5 treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast conserving surgery will be performed at 8-12 weeks after radiation to assess response to treatment. The primary outcome of the study will be feasibility, meaning the ability to deliver radiation treatment as planned. Secondary outcomes will include treatment related toxicity and pathological response.

If this study shows that SBRT can be used to treat patients primarily, it will lead to further evaluation of SBRT for early breast cancer.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stereotactic body radiotherapy (SBRT)	Experimental	Radiotherapy with SBRT to a dose of 40 Gy in 5 fractions delivered every other day over a period of 10-12 days, followed by breast conserving surgery.	Radiation: Stereotactic body radiotherapy (SBRT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stereotactic body radiotherapy (SBRT)	Radiation		Stereotactic body radiotherapy (SBRT)	Cyberknife

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility	The primary outcome for this study will be successful delivery of SBRT as per protocol without a major deviation.	At time of radiation treatment delivery

Secondary Outcomes

Measure	Description	Time Frame
Acute Radiation Toxicity		Within 3 months from radiation
Late Radiation Toxicity		3 months or more after radiation
Pathological Response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women age ≥ 70 years;
New histological diagnosis of invasive carcinoma of the breast, grade I or II, estrogen and progesterone receptor (ER and PR) positive, HER2 negative on needle biopsy and limited to Stage I (T1 N0 M0) on clinical and radiological assessment with MRI of the breasts and axillary ultrasound;
Candidate for breast conserving surgery;
Signed study consent form completed prior to study entry.

Exclusion Criteria:

Breast cancer with disease within 5 mm from skin or chest wall;
Previous or concomitant invasive malignancies treated within 5 years of study entry;
Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus or scleroderma), which would preclude to definitive radiation therapy;
Psychiatric disorders, which would preclude from obtaining informed consent
Geographic inaccessibility for follow-up

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shelley Chambers, MA	Contact	905-387-9711	64510	shelley.chambers@jcc.hhsc.ca
Julie Arsenault, MD, FRCPC	Contact	905-387-9495		julie.arsenault@jcc.hhsc.ca

Overall Officials

Name	Affiliation	Role
Julie Arsenault, MD, FRCPC	Juravinski Cancer Centre	Principal Investigator
Do-Hoon Kim, BASc, MD, MSc, FRCPC	Juravinski Cancer Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Juravinski Cancer Centre	Recruiting	Hamilton	Ontario	L8V 5C2	Canada

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

Intervention Browse Module

MeSH Terms

ID	Term
D016634	Radiosurgery

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided