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

Phase 2TerminatedNCT03852979

The Netherlands Cancer Institute1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancer

Interventions

PaclitaxelDRUG

weekly paclitaxel 80 mg/m2 for 12 weeks

CarboplatinDRUG

weekly carboplatin AUC=2 for 12 weeks

conisationPROCEDURE

if tumor is reduced to \<2 cm, patients will be treated with a conisation

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

NKI-AVL

Amsterdam, Netherlands

Outcomes

Primary Outcomes

efficacy of neo-adjuvant chemotherapy

efficacy of neo-adjuvant chemotherapy on tumor response

Time frame: week 6 of neoadjuvant treatment

safety of neo-adjuvant chemotherapy

defined as number of women who get recurrence within two years after conisation

Time frame: 2 years after conisation

Secondary Outcomes

fertility

number of patients who are still fertile after treatment

Time frame: 5 years after treatment

ovarian function

hormone levels will be measured to evaluate ovarian function

Time frame: 2 years after conisation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.