Image-guided Adaptive Radiotherapy for Cervix Cancer: Pat... | NCT00571415

Studies
Image-guided Adaptive Radiotherapy for Cervix Cancer: Patient Image Acquisition

NCT00571415

Sponsor

Virginia Commonwealth University

Status

Terminated

Last Update Posted

Jun 1, 2016Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Cervix Cancer

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
P01CA116602	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to competing studies no further subjects could be recruited.

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

May 2013Actual

Completion Date

Oct 2015Actual

First Submitted Date

Dec 11, 2007

First Submission Date that Met QC Criteria

Dec 11, 2007

First Posted Date

Dec 12, 2007Estimated

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

May 27, 2016

Last Update Posted Date

Jun 1, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

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

Within this study patient data are collected from different imaging and motion monitoring devices that will be used to develop and test strategies for image-guided adaptive radiotherapy in cervix cancer patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Label	Type	Description	Intervention Names
cervix cancer patients

Measure	Description	Time Frame
Increase in therapeutic ratio		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological diagnosis of cervix cancer
Prescription of radiation treatment to the primary cancer

Exclusion Criteria:

Prior radiation treatment to the pelvis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

University hospital clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey F Williamson, PhD	Virginia Commonwealth University, Department of Radiation Oncology	Principal Investigator
Jeffrey F Williamson, PhD	VCU, Richmond, VA	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Viriginia Commonwealth University, Department of Radiation Oncology		Richmond	Virginia	23298	United States

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided