Titre FIGO 2018 Stage IB2 (?2 to <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
Protocole ID CoNteSSa (NeoCon-F)
ClinicalTrials.gov ID NCT04016389
Type(s) de cancer Col
Phase Autres
Type étude Clinique
Médicament Chimiothérapie néo-adjuvante
Ville Montréal
Investigateur(trice) principal(e) Dre Vanessa Samouëlian
Coordonnateur(trice) France Gauthier
 514-890-8000 poste 30921
Statut Actif en recrutement
Critètes d'éligibilité 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 ≥2cm to <4cm 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.
Critètes d'exclusion 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