Trial Status: Complete
Recruitment closed February 2016
This is a single-centre prospective phase 0 tranlational study for predicting response of high grade serious ovarian cancers to paclitaxel chemotherapy
Aim AND DESIGN
The aim of the OXO-PCR-01 trial is to improve understanding of the causes of chemotherapy resistance in patients with ovarian cancer.
There are two study groups -
- All patients who give consent to the trial enter the Tumour Mapping Group. Patients have a biopsy taken by key-hole surgery to test their ovarian cancer. Patients then have the treatment which is standard care for their cancer (chemotherapy with paclitaxel and carboplatin followed by surgery). The patient donates a second set of samples during the surgery so their tumours can be compared before and after chemotherapy. This will allow the researchers to see how the chemotherapy has affected their tumours.
- In addition to the Tumour Mapping Group, if a patient gives consent they can enter the Single-Dose Group. After the key-hole biopsy, but before starting standard chemotherapy, patients have some extra scans and procedures and then receive an additional dose of paclitaxel. More samples are taken before and after the single dose of paclitaxel allowing the researchers to see how the paclitaxel has affected the cancer under closely controlled conditions. Patients then go on to receive the standard chemotherapy and donate additional samples at standard surgery as in the Tumour Mapping Group.
Tumour mapping group:
- To assess tumour response to standard chemotherapy treatment
Single Dose Group:
- To investigate the association between overexpression of βIIIâtubulin and paclitaxel resistance
- To investigate whether post-paclitaxel Mitotic Index (MI) is a determinant of paclitaxel response in ovarian cancer
- To investigate whether early tumour response evidenced by positron emission tomography (PET) and computerised tomography (CT) correlates with overall tumour response to neoadjuvant chemotherapy