Tumoroids in cervical cancer: tumor cultures to test sensitivity for treatment and to compare with clinical outcomes after neo-adjuvant therapy.
- Conditions
- cancer of the cervixcervical cancer10038594
- Registration Number
- NL-OMON54137
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
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 <=4cm by magnetic radiological imaging (MRI). Lymphovascular space
invasion (LVSI) is allowed.
• Patients must be >=18 years of age, and < 40 years of age
• Patients must be premenopausal and wish to preserve fertility
• At time of registration, patient may not have had any prior therapy to treat
their cancer lesion, patients with diagnostic cone or LEEP are allowed
• Eastern Cooperative Group (ECOG) performance status <= 2 (Karnofsky >=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 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Optimizing procedures for ex-vivo tumor testing for cervical cancer<br /><br>Evaluation of success rates of ex vivo drug sensitivity testing for cervical<br /><br>cancer patients eligible for NACT<br /><br>explorative testing of ex vivo immune drug sensitivity for cervical cancer.<br /><br>identification of tumor characteristics/ biomarkers/molecular markers that<br /><br>predict response to multiple neo adjuvant chemotherapy options.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the correlation between ex vivo drug sensitivity using tumor tissue<br /><br>derived before chemotherapy and the clinical response in women with cervical<br /><br>cancer who wish to preserve fertility and are treated with neo-adjuvant<br /><br>chemotherapy in order to enable less radical surgery.</p><br>