Neoadjuvant chemotherapy followed by surgery for cervical cancer patients wanting to preserve fertility
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
This study tests if giving chemotherapy before surgery can help women with cervical cancer keep their ability to have children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 4 sites (Houston, Texas and 3 other locations) |
| Trial ID | NCT04016389 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with invasive cervical cancer who wish to maintain their fertility after treatment. Participants will first receive neoadjuvant chemotherapy using platinum-based drugs, followed by imaging to assess their response. If the treatment is effective, they will undergo a trachelectomy, a fertility-sparing surgical procedure. Those who do not respond will receive alternative treatments, including chemotherapy, radiotherapy, or a hysterectomy.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women with FIGO 2018 Stage IB2 cervical cancer who wish to preserve their fertility.
Not a fit: Patients with advanced cervical cancer or those who have received prior treatment for their cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help preserve fertility in women diagnosed with cervical cancer.
How similar studies have performed: Other studies have explored neoadjuvant chemotherapy in cervical cancer, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 - 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
Where this trial is running
Houston, Texas and 3 other locations
- MD Anderson Cancer Centre — Houston, Texas, United States (Terminated)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- L'Hôtel-Dieu de Québec — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Stephanie Lheureux, M.D. — Princess Margaret Cancer Centre
- Study coordinator: Stephanie Lheureux, M.D.
- Email: stephanie.lheureux@uhn.ca
- Phone: 416-946-2818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.