Intensity-modulated Radiation Therapy From 70Gy to 80Gy i... | NCT02974231

Studies
Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer

NCT02974231

Sponsor

Institut de Cancérologie de Lorraine

Status

Completed

Last Update Posted

Nov 28, 2016Estimated

Enrollment

240Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Intensity-modulated radiation therapy

Countries

Not provided

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Oct 10, 2016

First Submission Date that Met QC Criteria

Nov 25, 2016

First Posted Date

Nov 28, 2016Estimated

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 25, 2016

Last Update Posted Date

Nov 28, 2016Estimated

Description Module

Brief Summary

The objective is to report outcomes,including grade ≥2 overall late rectal and urinary toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)

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

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

240Actual

Name	Type	Description	Arm Group Labels	Other Names
Intensity-modulated radiation therapy	Radiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
grade≥ 2 overall late rectal 5 years after the end of radiotherapy		60 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive patients from June 2000 to December 2010 with

untreated histologically confirmed adenocarcinoma of the prostate
stage T1c-T4 N0 M0 according to the 1992 American Joint Committee on Cancer staging system

Exclusion Criteria:

Patients with positive pelvic lymphadenectomy or radiological positives nodes

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine

Sampling Method

Non-Probability Sample

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