Actively Recruiting
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
Led by University Health Network, Toronto · Updated on 2025-08-12
31
Participants Needed
4
Research Sites
459 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
H
Hotel Dieu Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring >2 cm to ≤4 cm by MRI imaging
- Are premenopausal and wish to preserve fertility
- Have not had any prior therapy for their cervical cancer lesion at registration
- Have an ECOG performance status of 2 or less
- Have normal organ and marrow function within 7 days before starting treatment
- Have no evidence of active uncontrolled infection (patients on antibiotics are eligible)
- Have measurable disease per RECIST 1.1 criteria
- Are able to understand and willing to sign informed consent
- Agree to use effective contraception before, during, and for at least one year after fertility-sparing surgery with a pregnancy test within 72 hours before registration
- Have completed 3 cycles of neo-adjuvant chemotherapy and achieved complete or partial response reducing lesion to less than 2 cm on exam and MRI for fertility-sparing surgery
You will not qualify if you...
- Have had chemotherapy, radiotherapy, or surgery for their cancer before
- Are receiving other investigational agents
- Have other cancers requiring ongoing treatment
- Have known or evidence of brain metastases
- Have a history of allergic reactions to paclitaxel, carboplatin, cisplatin, or similar compounds
- Have uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting study compliance
- Are pregnant or breastfeeding
- Have any condition that contraindicates study participation due to safety or compliance concerns
- Are unable to complete 3 cycles of neo-adjuvant chemotherapy
- Have suboptimal response to neo-adjuvant chemotherapy
- Have residual lesion larger than 2 cm or disease progression during chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
MD Anderson Cancer Centre
Houston, Texas, United States, 77030
Terminated
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
3
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
4
L'Hôtel-Dieu de Québec
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
Research Team
S
Stephanie Lheureux, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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