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

• Status: Terminated
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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