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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)
EU CTIS ID: 2023-507230-24-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Exclusion Criteria for Neoadjuvant Chemotherapy: Patients who have had chemotherapy or radiotherapy or surgery for their cancer. Patients with diagnostic cone or LEEP are allowed
- Exclusion Criteria for Fertility Sparing Surgery: Suboptimal response to neoadjuvant chemotherapy according to local investigator
- Exclusion Criteria for Fertility Sparing Surgery: Residual lesion > 2cm or disease progression while on chemotherapy
- Exclusion Criteria for Neoadjuvant Chemotherapy: Patients who are receiving any other investigational agents.
- Exclusion Criteria for Neoadjuvant Chemotherapy: Patients with other cancers requiring ongoing treatment. Patients with malignancies unrelated to their cervical cancer can be included if they have not required treatment for 2 years. Patient with baso cellular skin cancer are allowed.
- Exclusion Criteria for Neoadjuvant Chemotherapy: Patients with known / evidence of brain metastases are excluded from participation in this clinical trial.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Exclusion Criteria for Neoadjuvant Chemotherapy: Patients who have had chemotherapy or radiotherapy or surgery for their cancer. Patients with diagnostic cone or LEEP are allowed
- Exclusion Criteria for Fertility Sparing Surgery: Suboptimal response to neoadjuvant chemotherapy according to local investigator
- Exclusion Criteria for Fertility Sparing Surgery: Residual lesion > 2cm or disease progression while on chemotherapy
- Exclusion Criteria for Neoadjuvant Chemotherapy: Patients who are receiving any other investigational agents.
- Exclusion Criteria for Neoadjuvant Chemotherapy: Patients with other cancers requiring ongoing treatment. Patients with malignancies unrelated to their cervical cancer can be included if they have not required treatment for 2 years. Patient with baso cellular skin cancer are allowed.
- Exclusion Criteria for Neoadjuvant Chemotherapy: Patients with known / evidence of brain metastases are excluded from participation in this clinical trial.
- Exclusion Criteria for Neoadjuvant Chemotherapy: History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or cisplatin or other agents used in study.
- Exclusion Criteria for Neoadjuvant Chemotherapy: 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.
- Exclusion Criteria for Neoadjuvant Chemotherapy: Patients who are pregnant or breastfeeding
- Exclusion Criteria for Neoadjuvant Chemotherapy: 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.
- Exclusion Criteria for Fertility Sparing Surgery: Patient unable to complete 3 cycles of neoadjuvant chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.