NCT04016389

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
DRUG	Carboplatin	Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
DRUG	Paclitaxel	Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
PROCEDURE	Trachelectomy	Surgery to remove the cervix but keep the uterus intact.

Timeline

• Start date: 2020-02-11
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2019-07-11
• Last updated: 2025-08-12

Locations

4 sites across 2 countries: United States, Canada