Feasibility Study: Conservative Treatment in Cervical Cancer

Early Phase 1

• Conditions: Stage IB1 Cervical Cancer
• Interventions: Procedure: conservative treatment

• Registration Number: NCT02323841
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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.

Study Timeline

• Status Verified: 2014-02
• Study Start: 2014-03
• Primary Completion: 2014-03
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-12-23
• Last Update Submitted: 2014-12-23
• Study First Posted: 2014-12-24
• Last Update Posted: 2014-12-24
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Squamous cervical cancer or adenocarcinoma in FIGO stage IB1-IIA, tumor volume between > 2 and ≤ 4 cm (instrumental evaluation).
• Informed consensus
• Childbearing
• Fertility (through US and ormonal withdrawal pre - e post neoadjuvant chemotherapy
• ASA (American Society of Anesthesiologist) Class < 2

Exclusion Criteria

• ongoing pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
conservative treatment in cervix cancer	conservative treatment	we performed conservative treatment cervix cancer patients with IB FIGO stage without pelvic involvement

Primary Outcome Measures

Name	Time	Method
pregnancy rate	3 years	time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery.

Secondary Outcome Measures

Name	Time	Method
disease free survival	5 years	time of disease free surviva
Overall survival	5 years	Time to the last follow up/death

Trial Locations

Locations (1)

Giovanni Scambia; 🇮🇹 Rome, Italy