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)

niversity Health Network0 sites95 target enrollmentSeptember 6, 2023

ConditionsCervical cancer Therapeutic area: Diseases [C] - Neoplasms [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cervical cancer
Sponsor: niversity Health Network
Enrollment: 95
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 6, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

niversity Health Network

Eligibility Criteria

Inclusion Criteria

•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 72 hours 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 7 days of the proposed start of treatment, patients must have normal organ and marrow function as defined: ? Haemoglobin \> 100 g/L ? Leukocytes (WBC) \> 3\.0x109 /L ? absolute neutrophil count \=1\.5x109 /L ? platelets \=100x109 /L ? total bilirubin within normal institutional limits ? AST(SGOT)/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.

Exclusion Criteria

•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