FIGO 2018 stage IB2 (>2cm - =4 cm) Cervical Cancer Treated with Neoadjuvant ChemotherapyFollowed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and ConservativeSurgery in Cervical Cancer to Preserve Fertility (NeoCon-F)

Princess Margaret Cancer Centre0 sites90 target enrollmentDecember 14, 2020

Overview

No summary available.

Registry

who.int

Start Date

December 14, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Patients must have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring \>2cm to \=4cm
•Patients must be \=18 years of age, and \< 40 years of age
•Patients must be premenopausal and wish to preserve fertility
•no 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
•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
•Patient must have disease that is measurable per RECIST 1\.1\.
•Ability to understand and willing to sign a written informed consent document.
•A negative serum pregnancy test

•Patients who have had chemotherapy or radiotherapy or surgery for their cancer. Patients with diagnostic cone or LEEP are allowed
•Patients who are receiving any other investigational agents.
•Patients with other cancers requiring ongoing treatment.
•Patients with known / evidence of brain metastases
•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
•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.