NCT00432445

Brief Summary

The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 27, 2015

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

7.1 years

First QC Date

February 5, 2007

Results QC Date

February 12, 2015

Last Update Submit

February 12, 2015

Conditions

Retinoblastoma

Keywords

Children with retinoblastomaRetinoblastomaPediatricsProton Beam Radiation TherapyRadiation TherapyTumor of the EyeOphthalmic EUAExamination under anesthesiaBilateral retinoblastomaUnilateral retinoblastomaExtraocular diseaseIntraocular procedure

Outcome Measures

Primary Outcomes (1)

  • Rate of Local Control in the Globe at 12 Months

    Where proton beam radiation therapy used as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention, local tumor control measured for participants with a globe as tumor regression with ocular retention, and for post enucleation measured as lack of orbital tumor recurrence.

    12 months

Study Arms (1)

Proton Beam Radiation Therapy

EXPERIMENTAL

Radiation given daily for 5 days in a row each week (except for Saturdays, Sundays, and holidays). The whole treatment will take about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary)

Radiation: Proton Beam Radiation TherapyProcedure: Ophthalmic EUA

Interventions

Proton Beam Radiation TherapyRADIATION

Radiation given daily for 5 days in a row each week (except for Saturdays, Sundays, and holidays). The whole treatment will take about 4-6 weeks.

Proton Beam Radiation Therapy
Ophthalmic EUAPROCEDURE

Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary)

Also known as: eye exam, ophthalmic exam
Proton Beam Radiation Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Active or recurrent retinoblastoma patient eligible for treatment of external beam radiation therapy.
  • A parent or guardian who can provide informed consent to a minor or child participant.
  • No concurrent infection.
  • No contraindication for repeated general anesthesia/sedation.

You may not qualify if:

  • Inability to return for multiple examinations under anesthesia.
  • Medical contraindication for exams under anesthesia/sedation.
  • Unreliable follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

RetinoblastomaEye Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Results Point of Contact

Title
Dan Gombos, MD/Professor, Ophthalmology
Organization
University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org
713-792-6920

Study Officials

  • Dan Gombos, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 7, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 27, 2015

Results First Posted

February 27, 2015

Record last verified: 2015-02

Locations

US(1)