Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) are as effective as 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will be randomized to receive chemotherapy(CEV) of 3 cycles or 6 cycles on a monthly basis. Patients will be followed for 24 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 3 cycles chemotherapy Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months. |
Drug: 3 cycles chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
Other Names:
|
| Active Comparator: 6 cycles chemotherapy Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months. |
Drug: 6 cycles chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- disease-free survival [five years]
measure the disease-free survival rate for the two group at five years
Secondary Outcome Measures
- side effects of chemotherapy in the Treatment of Retinoblastoma [up to two years]
Number of participants with side effects(systemic check-up, audio acuity)before each treatment, and 1,3,6,9,12,18,24 months after the treatment.
- quality of life (PedsQL4.0 scale) in the Treatment of Retinoblastoma [up to two years]
quality of life (PedsQL4.0 scale) before each treatment, and 1,3,6,9,12,18,24 months after the treatment.PedsQL 4.0 questionnaire has two modules (reported by parents and children) with 23 items encompassing the physical domains (8 items), emotional (5 items), social (5 items) and school (5 items). A five scores scale is used, after being asked, ''How much, in the last month, your child has had problems with'' (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = is often a problem and 4 = almost always a problem). The items are reverse-score and linearly transformed to a scale from 0 to 100 (0=100, 1=75, 2=50, 3=25, 4 = 0). So high scores indicate better QoL.
- side effects of chemotherapy in the Treatment of Retinoblastoma [five years]
Number of participants with side effects side effects(systemic check-up, audio acuity)before each treatment, and 1,3,6,9,12,18,24,36,48,52,60 months after the treatment.
- quality of life (PedsQL4.0 scale) in the Treatment of Retinoblastoma [five years]
quality of life (PedsQL4.0 scale) before each treatment, and 1,3,6,9,12,18,24,36,48,52,60 months after the treatment.PedsQL 4.0 questionnaire has two modules (reported by parents and children) with 23 items encompassing the physical domains (8 items), emotional (5 items), social (5 items) and school (5 items). A five scores scale is used, after being asked, ''How much, in the last month, your child has had problems with'' (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = is often a problem and 4 = almost always a problem). The items are reverse-score and linearly transformed to a scale from 0 to 100 (0=100, 1=75, 2=50, 3=25, 4 = 0). So high scores indicate better QoL.
- all cause mortality [two years]
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years
Eligibility Criteria
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.
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Received enucleation in the study eye.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Sun Yat-sen University
- Fudan University
Investigators
- Study Chair: Huasheng Yang, Doctor, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- yanghs20130507