FIGO 2018 stage IB2 (>2cm - <=4 cm) Cervical Cancer Treated with Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility (NeoCon-F)
- Conditions
- cervical cancercervical carcinoma10038594
- Registration Number
- NL-OMON54356
- Lead Sponsor
- Princess Margaret Cancer Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Patients must have histologically confirmed invasive cervical cancer with
adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring
>2 cm - <=4 cm
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
Patients who are receiving any other investigational agents.
Patients with other cancers requiring ongoing treatment.
Patients with known / evidence of brain metastases
Uncontrolled inter-current illness
Patients who are pregnant or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>to determine the rate of functional uterus defined as successful fertility<br /><br>sparing surgery (FSS) with no adjuvant therapy</p><br>
- Secondary Outcome Measures
Name Time Method <p>response rate based on RECIST 1.1 following neoadjuvant chemotherapy<br /><br>safety of the fertility sparing surgery (FSS)<br /><br>overall survival (OS) </p><br>