Clinical trial NCT03852979: Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
Official title: Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One arm two-stage Simon's design with response to neo-adjuvant chemotherapy as the primary endpoint
Primary purpose: TREATMENT

Brief summary: If no metastases are observed, patients will start a short protocol of four courses of weekly neo-adjuvant chemotherapy (12 weeks). If response to chemotherapy results in a tumor of less than 2 cm, cervical conisation will be performed.

Detailed description: The standard treatment of stage Ib1 2-4 cm cervical cancer in women who wish to preserve fertility is an abdominal radical trachelectomy with pelvic lymph node dissection. Since the number of take home babies after completing this procedure is below 10%, there is a need for exploration of alternative treatment modalities with better chances of preserving fertility at equal risk of recurrence. Since low fertility rates after abdominal radical hysterectomy are observed due to the radical surgery performed on the uterine cervix, less radical surgery is warranted. To enable less radical surgery by cervical conisation, neo-adjuvant chemotherapy to reduce tumor size is incorporated to the multi-modal treatment scheme of these patients.

Eligibility criteria: 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
* Laboratory values: serum creatinine \< 140 μmol/L; creatinine clearance \> 60 ml/min(Cockroft formula); white blood cell count \> 3.5 x 109/l; platelets \> 100 x 109 /l

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 malignancy

Primary outcomes:
measure: efficacy of neo-adjuvant chemotherapy
timeFrame: week 6 of neoadjuvant treatment
measure: safety of neo-adjuvant chemotherapy
timeFrame: 2 years after conisation
Secondary outcomes:
measure: fertility
timeFrame: 5 years after treatment
measure: ovarian function
timeFrame: 2 years after conisation
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI-AVL
Study officials:
References: