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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jul 8, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment approach for women with early-stage invasive cervical cancer who want to preserve their ability to have children after treatment. The study aims to find out if giving chemotherapy before surgery can help maintain fertility. Participants will receive a combination of two common chemotherapy drugs, cisplatin or carboplatin, along with paclitaxel, before undergoing fertility-sparing surgery. This could potentially reduce the long-term side effects of treatment, such as infertility.

To be eligible for the trial, patients must be premenopausal women with a specific type of cervical cancer that is larger than 2 cm but smaller than 4 cm. They should not have received any prior cancer treatment and must be able to understand and sign consent forms. After completing three cycles of chemotherapy, participants will undergo surgery if their cancer responds well. It's important for potential participants to know that they will need to use effective birth control during and after the study to ensure they do not become pregnant. This trial is currently recruiting participants who meet these criteria and are interested in exploring options to preserve their fertility while treating their cancer.

Gender

FEMALE

Eligibility 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