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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Malignant neoplasms of female genital organsMalignant neoplasms of ill-defined, secondary and unspecified sitesMalignant neoplasms of male genital organs
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Imaging;Management of Care;Active Monitoring;
You can take part if:
You may not be able to take part if:
1. Patients with any diagnoses not listed in the inclusion criteria of the protocol including: Pure dysgerminoma and pure seminoma, Pure mature teratoma, Pure immature teratoma COG Stage II - IV or FIGO Stage IC to IV, “Poor risk” GCT (age > = 11 years old and COG Stage IV ovarian, COG Stage III or IV EG, or IGCCC intermediate or poor risk testicular, or Primary CNS germ cell tumour). 2. Elevation of serum tumour markers without histologic confirmation. 3. Had no prior systemic therapy. 4. Had no prior radiation therapy except for CNS irradiation of brain metastases. 5. Patients with significant respiratory compromise due to either abdominal tumour limiting diaphragmatic excursion or pulmonary metastases. 6. Pregnancy and Breast Feeding - These criteria apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients): a) Female patients who are pregnant. b) Lactating females who plan to breastfeed their infants. c) Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Birmingham and funded by CANCER RESEARCH UK .
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Read full details
for Trial ID: CPMS 43262
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