AGCT1531
Research type
Research Study
Full title
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
IRAS ID
253574
Contact name
Anna Lawson
Contact email
Sponsor organisation
Children's Oncology Group
Eudract number
2018-004141-17
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
, ERN_18-0401
Duration of Study in the UK
10 years, 6 months, 1 days
Research summary
AGCT1531 is the first international Phase 3 randomised controlled trial for low and standard risk extra-cranial germ cell tumours (GCT) in children, teenagers and young adults (TYA).
Many cancers predominantly affecting TYA patients are considered rare because the incidence is low during early childhood and in older patients. However, GCTs are the third most common cancer diagnosed in the TYA population. Most patients with a GCT can expect cure, however, TYA outcomes are much worse than in children and adults.
The trial aims to answer several questions. Firstly, the removal of chemotherapy in low risk patients who are likely to be cured with surgery alone to reduce side effects will be assessed. These patients will undergo continued observation following surgery. Secondly; two different chemotherapy regimens in patients requiring chemotherapy following surgery will be compared: cisplatin, etoposide and bleomycin vs carboplatin, etoposide and bleomycin. In the UK, paediatric patients tend to be treated with a carboplatin based regimen, whereas TYA and adult patients tend to be treated with cisplatin-based regimens. This trial will directly compare the two regimens, and aim to assess whether carboplatin is as effective as cisplatin as well as less toxic.
Overall, the aim is to improve treatment for patients with GCTs by decreasing exposure to unnecessary chemotherapy or substituting a potentially less toxic drug while maintaining excellent survival and improving the quality of survival. It will also aim to identify why TYA patients may not do as well as other age groups. As part of this study, samples will be collected and stored for analysis in a separate study investigating whether a new test developed in the lab (microRNAs) can be used to help us better understand the presence of disease at diagnosis, when it may recur and how it may respond to treatment.REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0216
Date of REC Opinion
7 Aug 2020
REC opinion
Further Information Favourable Opinion