Study of Neo-Adjuvant Chemotherapy and Surgery to Preserve Fertility in Patients With Cervical Cancer
Study of Neo-Adjuvant Chemotherapy and Surgery to Preserve Fertility in Patients With Cervical Cancer
This study will include patients with invasive cervical cancer that wish to keep their
 fertility as much as possible in the future after treatment.

 Patients who receive surgery alone may experience long-term side effects including
 infertility. The purpose of this research study is to determine whether giving neo-adjuvant
 chemotherapy prior to surgery can maintain fertility in patients with invasive cervical
 cancer.

 The neo-adjuvant chemotherapy will consist of a platinum-based chemotherapy drug cisplatin or
 carboplatin, with a chemotherapy drug called paclitaxel. These are common chemotherapy drugs
 used in the treatment of women with cervical cancers.
All participants will first receive neo-adjuvant platinum-based chemotherapy. Once the
 neo-adjuvant chemotherapy has been completed, participants will be assessed by imaging scans
 to see whether they have a response to the treatment.

 If participants are responding to treatment, they will then have a trachelectomy. After
 surgery, participants will be assessed and the study doctor will determine whether adjuvant
 treatment is needed. Adjuvant treatment may include chemotherapy and radiotherapy, or have a
 hysterectomy done.

 If participants do not respond to or their disease worsens after neo-adjuvant treatment,
 participants will receive adjuvant treatment with chemotherapy and radiotherapy or have a
 hysterectomy done.
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 ≥2cm
 to <4cm 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