NCT03852979

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	weekly paclitaxel 80 mg/m2 for 12 weeks
DRUG	Carboplatin	weekly carboplatin AUC=2 for 12 weeks
PROCEDURE	conisation	if tumor is reduced to \<2 cm, patients will be treated with a conisation

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-02-25
• Last updated: 2020-01-10

Locations

1 site across 1 country: Netherlands