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

Official Title

FIGO 2018 Stage IB2 (≥2 to <4 cm) Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility

Summary:

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.

Trial Description

Primary Outcome:

• Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy

Secondary Outcome:

• Number of side effects
• Rate of completion of neo-adjuvant chemotherapy
• Response rate following neo-adjuvant chemotherapy
• Rate of fertility sparing surgery
• Surgical complication rate following fertility sparing surgery
• Rate of recurrence-free survival
• Rate of recurrence-free survival
• Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery
• Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery

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 radiation therapy, 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 radiation therapy or have a hysterectomy done.

View this trial on ClinicalTrials.gov