Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With… (NCT00499616) | Clinical Trial Compass
CompletedPhase 3
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
United States, Australia, Canada464 participantsStarted 2007-10-08
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor can be surgically removed. It is not yet known what is the minimal amount of chemotherapy needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and prevent tumor recurrence or metastases.
PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles administered and by allowing for up to 50% residual tumor volume for patients with localized disease.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/maturing subtype
* Newly diagnosed disease
* Intermediate-risk disease
* Needle biopsies or involved bone marrow are not sufficient for INPC histologic classification
* Meets 1 of the following criteria:
* Group 2
* International Neuroblastoma Staging System (INSS) stage 2A/2B; \< 50% resected or biopsy only; ≤ 12 years of age; MYCN-not amplified (NA); any histology and ploidy; normal 1p and 11q
* INSS stage 3; age \< 365 days; MYCN-NA; favorable histology (FH); hyperdiploid (DI) \> 1; normal 1p and 11q
* INSS stage 3; 365 days to 12 years of age; MYCN-NA; FH; normal 1p and 11q
* INSS stage 4S; age \< 365 days; MYCN-NA; FH; DI \>1; normal 1p and 11q; clinically symptomatic
* Group 3
* INSS stage 2A/2B; \< 50% resected or biopsy only; ≤ 12 years of age; MYCN-NA; any histology and ploidy; 1p loss of heterozygosity (LOH) and/or unb11q LOH (or data missing for either)
* INSS stage 3; age \< 365 days; MYCN-NA; FH; DI \> 1; 1p LOH and/or unb11q LOH (or data missing for either)
* INSS stage 3; age \< 365 days; MYCN-NA; DI = 1 and/or unfavorable histology (UH); normal 1p and 11q
* INSS stage 3; 365 days to 12 years of age; MYCN-NA; FH; 1p LOH and/or unb11q LOH (or data missing for either)
* INSS stage 4; age \< 365 days; MYCN-NA; FH; DI \> 1; normal 1p and 11q
* INSS stage 4S; age \< 365 days; MYCN-NA; either UH and any ploi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival (OS) Rates
Timeframe: 3 years
2
Definitive Determination of the Prognostic Ability of 1p and 11q
Timeframe: At baseline
3
Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961
Timeframe: Up to 3 years
4
Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961
Timeframe: Up to 3 years
5
Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma
Timeframe: Up to 3 years
6
Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment
Timeframe: From baseline to up to 10 years
7
Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS)