Adjuvant Chemotherapy for High-risk Postenucleation Retin... | NCT05080010

Studies
Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

NCT05080010

Sponsor

Sun Yat-sen University

Status

Recruiting

Last Update Posted

Oct 15, 2021Actual

Enrollment

500Estimated

Phase

Phase 3

Conditions

Retinoblastoma

Interventions

3 cycles chemotherapy

Countries

China

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 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Oct 2, 2021

First Submission Date that Met QC Criteria

Oct 2, 2021

First Posted Date

Oct 15, 2021Actual

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

Oct 2, 2021

Last Update Posted Date

Oct 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the effect of 3 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

Detailed Description

This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will receive 3 cycles of chemotherapy(CEV) oon a monthly basis. Patients will be followed for 60 months.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3 cycles chemotherapy	Experimental	Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.	Drug: 3 cycles chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3 cycles chemotherapy	Drug	Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.	3 cycles chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease-free survival	measure the disease-free survival rate at five years	five years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
Received enucleation in the study eye.
Monocular retinoblastoma.

Exclusion Criteria:

Any previous disease in the study eye.
Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
History of chemical intervention for retinoblastoma in the study eye.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huasheng Yang, M.D, PHD	Contact	+8620-87331539		yanghs64@126.com

Overall Officials

Name	Affiliation	Role
Huasheng Yang, M.D, PHD	Zhongshan Ophthalmic Center, Sun Yat-sen University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Ophthalmic Center, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012175	Retinoblastoma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014750	Vincristine
D016190	Carboplatin
D005047	Etoposide

Ancestor Terms

ID	Term
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided