Cervical Cancer
Conditions
Brief 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.
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.
Sponsors
Hotel Dieu Hospital
The Netherlands Cancer Institute
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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 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 -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of completion of neo-adjuvant chemotherapy | 2 years | — |
| Response rate following neo-adjuvant chemotherapy | 2 years | By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
| Rate of fertility sparing surgery | 2 years | — |
| Number of side effects | 2 years | By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Rate of recurrence-free survival | 2 years | — |
| Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery | 2 years | — |
| Surgical complication rate following fertility sparing surgery | 2 years | By Clavien-Dindo classification of surgical morbidity |
Countries
Canada, United States
Contacts
Primary ContactStephanie Lheureux, M.D.
Outcome results
None listed