NCT02323841

Feasibility Study: Conservative Treatment in Cervical Cancer

Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Currently conservative treatment for patients of childbearing affected by cervical cancer is reserved for women with FIGO stage IA2 - IB1 with tumor size less than 2 cm . The trachelectomy and the cone biopsy with pelvic lymphadenectomy are the choice for these patients wishing to preserve their reproductive function. In this context , recently literature show the results about the use of neo-adjuvant chemotherapy about the reduction of tumor volume and therefore the magnitude of the subsequent surgical treatment (including patients with tumors larger than 2 cm ). So it becomes crucial a prospective analysis on the possibility to include in this type of treatment patients with stage IB1 and IIA1 with tumor size greater than 2 cm ( up to 4 cm ) . The current study , in fact , would like to do a prospective evaluation on the advantages of neo-adjuvant chemotherapy in the possibility of broadening the inclusion criteria to conservative treatment in women , suffering from cervical cancer, stage IB1 and IIA1 ( with tumor volume between 2 and 4 cm) and wishing to preserve their reproductive function.

Detailed description

The investigators would like to be conservative in young patients affected by early stage cervical cancer.

Conditions

• Stage IB1 Cervical Cancer

Interventions

Type	Name	Description
PROCEDURE	conservative treatment	we performed pelvic lymphadenectomy before neoadjuvant chemotherapy and conization as conservative treatments

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-03-01
• Completion: 2015-03-01
• First posted: 2014-12-24
• Last updated: 2014-12-24

Locations

1 site across 1 country: Italy