eo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
- Conditions
- Women between 18 en 40 years with histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring >2cm to =4cmTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000404-11-NL
- Lead Sponsor
- Princess Margaret Cancer Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 90
Patients must have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring >2cm to =4cm
Patients must be =18 years of age, and < 40 years of age
Patients must be premenopausal and wish to preserve fertility
no prior therapy to treat their cancer lesion, patients with diagnostic cone or LEEP are allowed but a measurable tumor of >2 cm - =4 cm is mandatory
Eastern Cooperative Group (ECOG) performance status = 2
Within 7 days of the proposed start of treatment, patients must have normal organ and marrow function
No evidence of active uncontrolled infection
Patient must have disease that is measurable per RECIST 1.1.
Ability to understand and willing to sign a written informed consent document.
A negative serum pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 known / evidence of brain metastases
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
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
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method