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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
Surgery to remove the cervix but keep the uterus intact.
MD Anderson Cancer Centre
Houston, Texas, United States
TERMINATEDSunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGL'Hôtel-Dieu de Québec
Québec, Quebec, Canada
RECRUITINGRate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy
Time frame: 2 years
Number of side effects
By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 2 years
Rate of completion of neo-adjuvant chemotherapy
Time frame: 2 years
Response rate following neo-adjuvant chemotherapy
By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 2 years
Rate of fertility sparing surgery
Time frame: 2 years
Surgical complication rate following fertility sparing surgery
By Clavien-Dindo classification of surgical morbidity
Time frame: 2 years
Rate of recurrence-free survival
Time frame: 2 years
Rate of recurrence-free survival
Time frame: 3 years
Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery
Time frame: 2 years
Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery
Time frame: 3 years
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