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

Status: Terminated
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
NKI-AVL
Amsterdam
Time Frame
Start Date: 2018-11-01
Completion Date: 2020-01-01
Participants
Target number of participants: 1
Treatments
Experimental: neo-adjuvant chemotherapy
The patients are given weekly paclitaxel 80 mg/m2 + carboplatin AUC=2 (or AUC=6 per three weeks) during 12 weeks/4 courses followed by conization if tumor size is reduced to \<2 cm
Related Therapeutic Areas
Sponsors
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov

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