NCT04016389RecruitingPhase 2
FIGO 2018 stage IB2 (>2 cm - ≤4 cm ) Cervical Cancer Treated with Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility (NeoCon-F)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To assess the feasibility of preserving fertility in women with node negative, 2018 FIGO stage IB2 cervical cancer with lesions measuring >2 cm - ≤4 cm by administering neo-adjuvant chemotherapy (NACT) followed by fertility sparing surgery (FSS) and no adjuvant therapy
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 6 Sept 2023
- Start date
- 17 Feb 2021
- Lead sponsor
- University Health Network
- Diseases
- Cervical cancer
- NCT number
- NCT04016389
- EU CT number
- 2023-507230-24-00
- EudraCT number
- 2020-000404-11
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 28
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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 (T2 sequence MRI). Lymphovascular space invasion (LVSI) is allowed
- Eligibility Criteria for Neoadjuvant Chemotherapy: Patients must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least one year after the FSS procedure. A serum pregnancy test within 7 days prior to study registration is required.
- Eligibility Criteria for Fertility Sparing Surgery (FSS) Completed 3 cycles of neoadjuvant chemotherapy and achieved a complete response (CR) or partial response (PR) with reduction of the largest dimension of the lesion to <2 cm on physical examination and T2 sequence on MRI. For minimal MRI requirements: see Appendix F.
- Eligibility Criteria for Neoadjuvant Chemotherapy: Patients must be ≥18 years of age, and ≤40 years of age
- Eligibility Criteria for Neoadjuvant Chemotherapy: Patients must be premenopausal and wish to preserve fertility
- Eligibility Criteria for Neoadjuvant Chemotherapy: At time of registration, patient may not have had any prior therapy to treat their cancer lesion, patients with diagnostic cone or LEEP are allowed but a measurable tumor of >2 cm - ≤4 cm is mandatory
- Eligibility Criteria for Neoadjuvant Chemotherapy: Eastern Cooperative Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%, see Appendix C).
- Eligibility Criteria for Neoadjuvant Chemotherapy: Within 14 days of the proposed start of treatment, patients must have normal organ and marrow function as defined: Haemoglobin ≥ 100 g/L or ≥ 6.2 mmol/L Leukocytes (WBC) ≥ 3.0x109 /L absolute neutrophil count ≥1.5x109 /L platelets ≥100x109 /L total bilirubin within normal institutional limits AST(SGOT) and ALT(SGPT) ≤2.5 × institutional upper limit of normal creatinine within normal institutional limits
- Eligibility Criteria for Neoadjuvant Chemotherapy: No evidence of active uncontrolled infection (patients on antibiotics are eligible).
- Eligibility Criteria for Neoadjuvant Chemotherapy: Patient must have disease that is measurable per RECIST 1.1.
- Eligibility Criteria for Neoadjuvant Chemotherapy: Ability to understand and willing to sign a written informed consent document.
Age in the registry: 18 years to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Stichting Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.