Chemotherapy and Fertility-Sparing Surgery for Cervical Cancer
This study is for women aged 18-40 with invasive cervical cancer (FIGO 2018 IB2 stage) who want to preserve their fertility. It's testing if giving chemotherapy (Cisplatin or Carboplatin, plus Paclitaxel) before surgery can help maintain fertility. Currently, surgery alone can lead to infertility. The study aims to see if this approach allows for a successful fertility-sparing surgery (trachelectomy, which removes the cervix but keeps the uterus) without needing further treatment, measured at 2 years. The study plans to enroll 31 participants.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 31 participants. All participants will first receive chemotherapy.
- What's involved
- You would first receive chemotherapy. After that, imaging scans will check your response. If you respond, you will have a trachelectomy. After surgery, doctors will decide if you need more treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures the rate of functional uterus at 2 years after successful fertility-sparing surgery.
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NCT04016389
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
Recruiting
NAAges 18–40InterventionalTreatmentUniversity Health Network, TorontoInvestigator-initiated
~31 participants
Updated 2025-08-12 on ClinicalTrials.gov
What's tested:CisplatinCarboplatinPaclitaxelTrachelectomy
At a glance
Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy
Measured over 2 years
Conditions
Where it's being run
4 sites across 3 statesOntario2
Texas1
Quebec1
Study leadership
- Stephanie Lheureux, M.D. · PRINCIPAL_INVESTIGATOR · Princess Margaret Cancer Centre
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patients must have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring \>2 cm - ≤4 cm by radiological imaging (MRI).
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.
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 (patients on antibiotics are eligible).
Patient must have disease that is measurable per the Response Evaluation Criteria in Solid Tumors (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 fertility-sparing surgery (FSS) procedure. A serum pregnancy test within 72 hours prior to study registration is required.
Completed 3 cycles of neo-adjuvant chemotherapy and achieved a complete response (CR) or partial response (PR) with reduction of the lesion to \<2 cm on physical examination and MRI.
Exclusion
Patients who have had chemotherapy or radiotherapy or surgery for their cancer.
Patients who are receiving any other investigational agents.
Patients with other cancers requiring ongoing treatment.
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.
Patient unable to complete 3 cycles of neoadjuvant chemotherapy
Suboptimal response to neoadjuvant chemotherapy according to investigator
Residual lesion \> 2cm or disease progression while on chemotherapy
What this trial measures
- Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy2 years