| 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 |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 L'HOTEL-DIEU DE QUEBEC ET CRCEO
11 Côte du Palais, Québec, QC, G1R 2J6
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dre Marie Plante
|
| Coordonnateur(trice) |
Maryse Gingras
418-691-5781
|
| 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
|
Groupe d'étude en oncologie du Québec