RetinoblastomaPhase 2NCT00432445
Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma
A Phase 2 study testing Proton Beam Radiation Therapy and Ophthalmic EUA in people with Retinoblastoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Proton Beam Radiation Therapy and Ophthalmic EUA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to return for multiple examinations under anesthesia.
- Medical contraindication for exams under anesthesia/sedation.
- Unreliable follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Proton Beam Radiation Therapy for Intra- and Periocular Retinoblastoma
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.
Read the detailed description
External photon beam radiation therapy (which is current standard of care) has been used in the treatment of retinoblastoma. It is a form of radiation therapy in which the radiation is delivered by a machine pointed at the area to be radiated.
Proton beam radiation therapy is a form of external photon beam radiation therapy, but it may be more effective because its adjusted dosing delivers less radiation to surrounding areas of the tumor, which helps preserve other tissues and cause fewer side effects.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your eye doctor will perform an assessment of your eye, including an exam while you are under anesthesia. This exam will include a dilated eye exam, photography of your affected eye (by a Ret-Cam), ultrasound of your affected eye, and imaging scans, such as computed tomography (CT) or magnetic resonance imaging (MRI), if the doctor thinks it is necessary. The assessments will be done to check and confirm the status of the disease.
After diagnosis of retinoblastoma, the study doctor will first see if external photon beam radiation therapy is a reasonable treatment option for you. If external photon beam radiotherapy is deemed appropriate for you, you will be eligible to receive proton beam radiation therapy in this study.
If you are found to be eligible to take part in this study, you will be treated with proton beam radiation therapy. Treatment will begin within 1 week of referral to the M. D. Anderson Proton Center. It will be 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.
Within 2-4 weeks after completion of therapy, you will have an eye exam performed under anesthesia (like the one during screening). You will have repeated eye exams under anesthesia, depending on the appearance and response of the tumor to therapy. This will occur about every 1-4 months.
You will continue to have these eye exams until the tumors are considered to be stable or unless your disease gets worse.
If the disease gets worse or you experience any intolerable side effects, you may be taken off treatment.
You will be required to have lifelong eye and medical assessments to continue to monitor you for disease. If no disease is found 5 years after completion of proton beam radiation therapy, you will be considered free of disease. You will then have annual (yearly) eye and pediatric assessment through adulthood.
This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M.D. Anderson.
- Conditions
- Retinoblastoma
- Being tested
- Proton Beam Radiation Therapy, Ophthalmic EUA
- Keywords
- Children with retinoblastoma, Retinoblastoma, Pediatrics, Proton Beam Radiation Therapy, Radiation Therapy, Tumor of the Eye, Ophthalmic EUA, Examination under anesthesia, Bilateral retinoblastoma, Unilateral retinoblastoma, Extraocular disease, Intraocular procedure
- Medical subject headings
- Retinoblastoma, Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Ophthalmic EUAProcedure or surgery
Also called eye exam, ophthalmic exam
Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Radiation: Proton Beam Radiation Therapy; Procedure: Ophthalmic EUA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Gombos, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432445
- Sponsor's protocol ID
- 2005-0883
- Other IDs
- NCI-2012-01427
- Status last verified
- Feb 2015
- First submitted
- 5 Feb 2007
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Proton Beam Radiation Therapy for Intra- and Periocular Retinoblastoma
- ClinicalTrials.gov ID
- NCT00432445
- Acronym / sponsor ID
- 2005-0883
- Conditions
- Retinoblastoma
- Keywords
- Children with retinoblastoma, Retinoblastoma, Pediatrics, Proton Beam Radiation Therapy, Radiation Therapy, Tumor of the Eye, Ophthalmic EUA, Examination under anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Feb 2007 (estimated)
- Results
- Posted 27 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
External photon beam radiation therapy (which is current standard of care) has been used in the treatment of retinoblastoma. It is a form of radiation therapy in which the radiation is delivered by a machine pointed at the area to be radiated.
Proton beam radiation therapy is a form of external photon beam radiation therapy, but it may be more effective because its adjusted dosing delivers less radiation to surrounding areas of the tumor, which helps preserve other tissues and cause fewer side effects.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your eye doctor will perform an assessment of your eye, including an exam while you are under anesthesia. This exam will include a dilated eye exam, photography of your affected eye (by a Ret-Cam), ultrasound of your affected eye, and imaging scans, such as computed tomography (CT) or magnetic resonance imaging (MRI), if the doctor thinks it is necessary. The assessments will be done to check and confirm the status of the disease.
After diagnosis of retinoblastoma, the study doctor will first see if external photon beam radiation therapy is a reasonable treatment option for you. If external photon beam radiotherapy is deemed appropriate for you, you will be eligible to receive proton beam radiation therapy in this study.
If you are found to be eligible to take part in this study, you will be treated with proton beam radiation therapy. Treatment will begin within 1 week of referral to the M. D. Anderson Proton Center. It will be 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.
Within 2-4 weeks after completion of therapy, you will have an eye exam performed under anesthesia (like the one during screening). You will have repeated eye exams under anesthesia, depending on the appearance and response of the tumor to therapy. This will occur about every 1-4 months.
You will continue to have these eye exams until the tumors are considered to be stable or unless your disease gets worse.
If the disease gets worse or you experience any intolerable side effects, you may be taken off treatment.
You will be required to have lifelong eye and medical assessments to continue to monitor you for disease. If no disease is found 5 years after completion of proton beam radiation therapy, you will be considered free of disease. You will then have annual (yearly) eye and pediatric assessment through adulthood.
This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M.D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Beam Radiation Therapy | Experimental | Radiation: Proton Beam Radiation Therapy, Procedure: Ophthalmic EUARadiation 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Inability to return for multiple examinations under anesthesia.
- Medical contraindication for exams under anesthesia/sedation.
- Unreliable follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Beam Radiation TherapyRadiation 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. | Radiation | Proton Beam Radiation Therapy |
| Ophthalmic EUAAlso: eye exam, ophthalmic examOphthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary) | Procedure or surgery | Proton Beam Radiation Therapy |
Primary outcome
Rate of Local Control in the Globe at 12 Months
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Gombos, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proton Beam Radiation Therapy and Ophthalmic EUA in people with Retinoblastoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Local Control in the Globe at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.