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
University Health Network, Toronto
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.
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-adj…
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- No
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 marro…
Interventions
- DrugCisplatin
Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
- DrugCarboplatin
Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
- DrugPaclitaxel
Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
- ProcedureTrachelectomy
Surgery to remove the cervix but keep the uterus intact.
Locations (4)
- MD Anderson Cancer CentreHouston, Texas
- Sunnybrook Health Sciences CentreToronto, Ontario
- Princess Margaret Cancer CentreToronto, Ontario
- L'Hôtel-Dieu de QuébecQuébec, Quebec