FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery

Participation Requirements

• Sex:

  FEMALE

• Eligible Ages:

  18 to 40

Participation Criteria

Inclusion Criteria:

Part 1 - Eligibility Criteria for Neoadjuvant Chemotherapy

* 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.

Part 2 - Eligibility Criteria for Fertility Sparing Surgery (FSS)

* 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 Criteria:

Part 1 - Exclusion Criteria for Neoadjuvant Chemotherapy

* 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.

Part 2 - Exclusion Criteria for Fertility Sparing Surgery

* 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