eo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 120

Inclusion Criteria

•Stage Ib1 cervical cancer measuring =2 - =4 cm on physical examination and imaging in any direction
•Histologic type: squamous cell carcinoma (SCC), adeno cell carcinoma (ACC), adeno-squamous cell carcinoma (ASC)
•Lymph vascular space invasion allowed (LVSI)
•Age =18 years and = 40 years
•Wish to preserve fertility
•Written and signed informed consent
•Negative serum or urine pregnancy test within 14 days prior to registration, and an effective method of contraception must be used during treatment
•MRI abdomen and pelvis, chest X-ray must be performed and negative for metastatic disease within 12 weeks of enrolment
•No metastases on pelvic lymph node dissection

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Other high grade histologies like neuro-endocrine and clearcell carcinoma
•FIGO stage Ia, Ib1< 2 cm, Ib2, II, III and IV disease
•Involvement of tumor in uterine corpus on MRI or hysteroscopy if performed
•Evidence of metastatic disease on imagining (PET/CT/MRI) performed within 12 weeks of enrolment
•other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study (except non-melanoma skin cancer).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to determine the efficacy of neo-adjuvant chemotherapy to reduce tumour size below 2 cm in diameter and thus enabling conisation. ;Secondary Objective: Secondary objectives are recurrence-free survival for patients who received conisation, number of patients who kept the possibility to conceive (no hysterectomy performed, no radiation to pelvic area performed), ovarian function after treatment, quality of life, registration of pregnancies if they occur during follow-up, registration of concerns about fertility prior and after treatment. Translational research to predict response to neo-adjuvant chemotherapy. ;Primary end point(s): response to neo-adjuvant chemotherapy.;Timepoint(s) of evaluation of this end point: week 6 of neo-adjuvant treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): need for adjuvant therapy (radical hysterectomy or (chemo)radiation, preservation of ovarian function, quality of life. ;Timepoint(s) of evaluation of this end point: after 12, 24 and 60 months.

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