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

Ki vehet részt

• 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

Ki nem vehet részt

• Part 1 - Exclusion Criteria for Neoadjuvant Chemotherapy
• Patients who are receiving any other investigational agents
• Patient unable to complete 3 cycles of neoadjuvant chemotherapy
• Suboptimal response to neoadjuvant chemotherapy according to investigator
• Patients who have had chemotherapy or radiotherapy or surgery for their cancer
• Patients with other cancers requiring ongoing treatment
• 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
• 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
• Residual lesion > 2cm or disease progression while on chemotherapy
• Patients with known / evidence of brain metastases are excluded from participation in this clinical trial
• Patients who are pregnant or breastfeeding