Hypofractionated Stereotactic Linear Accelerator Radiothe... | NCT00872391

Studies
Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma

NCT00872391

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Mar 31, 2009Estimated

Enrollment

155Estimated

Phase

Not Applicable

Conditions

Uveal Melanoma

Interventions

Hypofractionated linear accelerator radiotherapy

Countries

Austria

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 2009

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

Mar 2009

Primary Completion Date

Mar 2024Estimated

Completion Date

Not provided

First Submitted Date

Mar 30, 2009

First Submission Date that Met QC Criteria

Mar 30, 2009

First Posted Date

Mar 31, 2009Estimated

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, 2009

Last Update Posted Date

Mar 31, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to assess the safety and efficacy of hypofractionated stereotactic LINAC radiotherapy with 10 fractions at 6 Gy per fraction at the 80% isodose for the planning target volume (PTV) in patients with uveal melanoma. Patients will be followed-up for 10 years after radiotherapy regarding local tumor control, visual acuity, secondary complications and survival.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

155Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypofractionated LINAC radiotherapy	Experimental		Radiation: Hypofractionated linear accelerator radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypofractionated linear accelerator radiotherapy	Radiation	10 fractions of stereotactic linear accelerator radiotherapy with 6 Gy per fraction at the 80% isodose for the planning target volume.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
local tumor control (tumor dimensions; secondary complications; visual acuity; survival

Secondary Outcomes

Measure	Description	Time Frame
histological assessment of the fraction of living cells in eyes requiring secondary enucleation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The initial height of the melanoma is 7 mm or higher.
Juxtapapillary and/or juxtamacular melanomas with a height of 3 mm or higher and if the central tumor distance to the optic disc and/or the macula is 3 mm or less.
If other forms of conservative treatment of the melanoma are not possible.

Exclusion Criteria:

Prior/Concomitant Treatment.
Extrascleral tumor extension is present.
If the presence of neovascular glaucoma is detected before treatment.
If metastasis is detected at baseline.
Previous participation in any study of investigational drugs within 3 month preceding day 0.
Pregnant women are not allowed to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martin Zehetmayer, MD	Contact	+431 40400	7941	martin.zehetmayer@meduniwien.ac.at
Karin Dieckmann, MD	Contact	+431 40400	2709	karin.dieckmann@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Martin Zehetmayer, MD	Department of Ophthalmology, Medical University of Vienna, Austria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of Vienna	Recruiting	Vienna	State of Vienna	1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D000098943	Uveal Melanoma

Ancestor Terms

ID	Term
D008545	Melanoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided