Status:
RECRUITING
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Hotel Dieu Hospital
The Netherlands Cancer Institute
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 l...
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 ...
Eligibility Criteria
Inclusion
- 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
- Part 1 - Exclusion Criteria for Neoadjuvant Chemotherapy
- Patients who have had chemotherapy or radiotherapy or surgery for their cancer.
- Patients who are receiving any other investigational agents.
- Patients with other cancers requiring ongoing treatment.
- Patients with known / evidence of brain metastases are excluded from participation in this clinical trial.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or cisplatin or other agents used in study.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who are pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues.
- Part 2 - Exclusion Criteria for Fertility Sparing Surgery
- Patient unable to complete 3 cycles of neoadjuvant chemotherapy
- Suboptimal response to neoadjuvant chemotherapy according to investigator
- Residual lesion \> 2cm or disease progression while on chemotherapy
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04016389
Start Date
February 11 2020
End Date
December 1 2028
Last Update
August 12 2025
Active Locations (4)
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1
MD Anderson Cancer Centre
Houston, Texas, United States, 77030
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
3
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
4
L'Hôtel-Dieu de Québec
Québec, Quebec, Canada, G1R 2J6