The Role of Tomotherapy in Hypofractionated/Dose Escalate... | NCT00126802

Studies
The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer

NCT00126802

Sponsor

AHS Cancer Control Alberta

Status

Unknown status

Last Update Posted

Jul 6, 2016Estimated

Enrollment

60Actual

Phase

Phase 1Phase 2

Conditions

Prostate Cancer

Interventions

Tomotherapy

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

Official Title

The Role of Tomotherapy (Dynamic IMRT and Megavoltage CT Scanning) in Hypofractionated/Dose Escalated Conformal Radiation Treatment Using Magnetic Resonance Spectroscopy (MRS) Scans to Predict and Document the Pattern of Local Failure for High Risk Prostate Cancer

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Aug 3, 2005

First Submission Date that Met QC Criteria

Aug 3, 2005

First Posted Date

Aug 5, 2005Estimated

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

Jul 4, 2016

Last Update Posted Date

Jul 6, 2016Estimated

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

Helical tomotherapy is being used to treat the prostate gland, local rates of spread and regional lymph nodes whilst sparing gross structures. The radiation to the gross disease in the prostate is hypofractionated and dose escalated. Magnetic resonance spectroscopic imaging (MRSI) is incorporated into pre- and post-treatment evaluation.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tomotherapy	Procedure	Standard 45 Gy in 25 fractions in 5 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rectal Toxicity	Determine the acute and late rectal toxicity of high-dose short-course hypofractionated radiotherapy in five weeks in the treatment of high rish prostate cancer.	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
prostate-specific antigen (PSA) and MRSI disease control	Determine the biochemical control (freedom from PSA failure) rate, overall and disease free survival.	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High risk localized prostate cancer

Exclusion Criteria:

Low/intermediate risk, metastatic cancer
Patient refusal

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Pearcey, MD	AHS Cancer Control Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cross Cancer Institute		Edmonton	Alberta	T6G 1Z2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050397	Radiotherapy, Intensity-Modulated

Ancestor Terms

ID	Term
D020266	Radiotherapy, Conformal
D011881	Radiotherapy, Computer-Assisted
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided