RetinoblastomaPhase 3NCT04799002
Topotecan and Melphalan for Retinoblastoma
A Phase 3 study testing Topotecan and Melphalan in people with Retinoblastoma and Chemotherapy Effect, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate topotecan and melphalan for retinoblastoma patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinoblastoma, Chemotherapy Effect
- What is being tested?
- Topotecan and Melphalan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2021to 30 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- diagnosed as retinoblastoma
- receiving eyeball-sparing treatment
Who cannot join
- disease progression during follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guangzhou, Guangdong, 510000
Huijing Ye, Doctor, 00862087331539, yehuijing@qq.com
Huasheng Yang, Doctor, 00862087331539, yanghs64@126.com
About this study
Official title: Choice of Topotecan or Melphalan in Retinoblastoma Patients
The purpose of this study is to evaluate topotecan and melphalan for retinoblastoma patients.
Read the detailed description
To evaluate the effectiveness and complications of topotecan and melphalan for intraocular injection in retinoblastoma patients.
- Conditions
- Retinoblastoma, Chemotherapy Effect
- Keywords
- Retinoblastoma, topotecan, Melphalan
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
Also called Topotecan intraocular injection
Topotecan intraocular injection for chemotherapy in retinoblastoma
MelphalanDrug
Also called Melphalan intraocular injection
Melphalan intraocular injection for chemotherapy in retinoblastoma
| Study group | Role | What they receive |
|---|---|---|
| Topotecan | Active comparator | Topotecan intraocular injection during chemotherapy Receives: Drug: Topotecan |
| Melphalan | Experimental | Melphalan intraocular injection during chemotherapy Receives: Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyeball-sparing rate
Eyeball-sparing rate during chemotherapy in retinoblastoma patients
Measured: 5 years after chemotherapy
Secondary outcomes (1)
Side effects
Side effects during and after chemotherapy in retinoblastoma patients
Measured: 5 years after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start11 Mar 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huasheng Yang, Sun Yat-sen University
- Investigators
- Huashen Yang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799002
- Sponsor's protocol ID
- 202103
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Topotecan or Melphalan in Retinoblastoma Patients
- ClinicalTrials.gov ID
- NCT04799002
- Acronym / sponsor ID
- 202103
- Conditions
- Retinoblastoma, Chemotherapy Effect
- Keywords
- Retinoblastoma, topotecan, Melphalan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
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 study is to evaluate topotecan and melphalan for retinoblastoma patients.
Detailed description
To evaluate the effectiveness and complications of topotecan and melphalan for intraocular injection in retinoblastoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topotecan | Active comparator | Drug: TopotecanTopotecan intraocular injection during chemotherapy |
| Melphalan | Experimental | Drug: MelphalanMelphalan intraocular injection during chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed as retinoblastoma
- receiving eyeball-sparing treatment
Key exclusion criteria (1 listed)
- disease progression during 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 |
|---|---|---|
| TopotecanAlso: Topotecan intraocular injectionTopotecan intraocular injection for chemotherapy in retinoblastoma | Drug | Topotecan |
| MelphalanAlso: Melphalan intraocular injectionMelphalan intraocular injection for chemotherapy in retinoblastoma | Drug | Melphalan |
Primary outcome
Eyeball-sparing rate
Time frame: 5 years after chemotherapy
Eyeball-sparing rate during chemotherapy in retinoblastoma patients
1 secondary outcome
Side effects
Time frame: 5 years after chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Huashen Yang principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topotecan and Melphalan in people with Retinoblastoma and Chemotherapy Effect, run by Sun Yat-sen University at 1 site in China.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Mar 2021. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huasheng Yang (+00862087331539, yanghs64@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyeball-sparing rate (time frame: 5 years after chemotherapy). 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 16 Mar 2021.