AGCT1531. A Phase 3 study of active surveillance for low risk and a randomized trial of carboplatin vs.cisplatin for standard risk pediatric and adult patients with germ cell tumors.
Categories (click each to see list of all clinical trials associated with that category): CTO Pediatric Trials (ONC), Pediatric (PEDONC)
Current Status: Open
Phase: III
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT03067181?term=NCT03067181&rank=1
Summary
Primary Objectives.
1) Overall survival [ Time Frame: The time from randomization to date of date of death or date of last follow-up and ascertained as alive, assessed up to 8 years ]
A 1-sided lower 85% confidence limit for the 2-year survival will be constructed, and if this confidence limit is greater than 0.95, it will be concluded that the strategy provides sufficient overall survival.
2)Event-free survival [ Time Frame: The time from study entry to the date of death, date of disease progression or recurrence, date of second malignant neoplasm or date of last contact and ascertained as alive, whichever comes first, assessed up to 5 years ]
Will compare between a carboplatin-based regimen versus a cisplatin-based regimen.
Secondary Outcomes.
1) Incidence of ototoxicity [ Time Frame: 4 weeks after the last dose of platin therapy ]
Will compare the proportion of patients who demonstrate hearing loss according to the International Society of Pediatric Oncology criteria.
2) Content validity and understandability of Adolescents and Young Adults-Hearing Screen [ Time Frame: Baseline ]
Will be assessed by questionnaire.
3) Utility of the 4-micro ribonucleic acid panel as markers diagnostic of mediastinal germ cell tumors [ Time Frame: Up to 10 years ]
Will use categorical data methods and estimate the probability of demonstrating an elevated micro ribonucleic acid value as the proportion of patients who have the particular micro ribonucleic acid elevated.
4) Utility of the 4-micro ribonucleic acid panel as markers diagnostic of mediastinal germ cell tumors [ Time Frame: Up to 10 years ]
Will compare the diagnostic sensitivity of serum markers, particularly elevated alpha-fetoprotein, to that of elevated micro ribonucleic acid for each of the micro ribonucleic acids, as well as the characteristic any micro ribonucleic acid elevated. Will perform McNemar?s test. The result for each serum evaluation (elevated or not elevated) for each sample on which both serum marker and micro ribonucleic acid evaluation are obtained will be cross tabulated and the p-value associated with McNemar?s test calculated. A p-value of 0.05 or less will be considered evidence of differential sensitivity.
5) Novel genetic variants associated with an increased risk of platinum-associated ototoxicity as determined by standard audiology [ Time Frame: Up to 10 years ]
For each candidate gene, will perform an exact two-sided test for the equality of binomial proportions for the event ? patient has the candidate gene. The two groups compared will be defined by the presence of significant hearing loss. Will use the Bonferroni correction to control experiment-wise error and designate the result as significant if the observed p-value is less than or equal to 0.0025.