Feasibility Study: Conservative Treatment in Cervical Cancer

Catholic University of the Sacred Heart

Status and phase

Unknown

Early Phase 1

Conditions

Stage IB1 Cervical Cancer

Treatments

Procedure: conservative treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02323841

12650/13

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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