cancer of the cervix cervical cancer
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients are eligible for this study in case they meet the following inclusion criteria: • Patients must have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring >2cm to =18 years of age, and =60%, see Appendix C). No evidence of active uncontrolled infection (patients on antibiotics are eligible). Patient must have disease that is measurable per RECIST 1.1. • Ability to understand and willing to sign a written informed consent document. • Patients must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least one year after the FSS procedure.
Exclusion criteria
Exclusion criteria: Exclusion criteria for this study: • Patients who have had chemotherapy or radiotherapy or surgery for their cancer. Patients with diagnostic cone or LEEP are allowed • Patients who are receiving any other investigational agents. • Patients with other cancers requiring ongoing treatment. Patients with malignancies unrelated to their cervical cancer can be included if they have not required treatment for 2 years. Patient with baso cellular skin cancer are allowed. • Patients with known / evidence of brain metastases are excluded from participation in this clinical trial. • History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or cisplatin or other agents used in study. • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. • Patients who are pregnant or breastfeeding • Any other condition that would, in the Investigator*s judgment, contraindicate the patient*s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimizing procedures for ex-vivo tumor testing for cervical cancer Evaluation of success rates of ex vivo drug sensitivity testing for cervical cancer patients eligible for NACT explorative testing of ex vivo immune drug sensitivity for cervical cancer. identification of tumor characteristics/ biomarkers/molecular markers that predict response to multiple neo adjuvant chemotherapy options. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the correlation between ex vivo drug sensitivity using tumor tissue derived before chemotherapy and the clinical response in women with cervical cancer who wish to preserve fertility and are treated with neo-adjuvant chemotherapy in order to enable less radical surgery. | — |
Countries
Netherlands
Outcome results
None listed