Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Stage IB1 Cervical Cancer
- Sponsor
- Catholic University of the Sacred Heart
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- pregnancy rate
- Last Updated
- 11 years ago
Overview
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.
Investigators
Prof. Giovanni Scambia
Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm
Catholic University of the Sacred Heart
Eligibility Criteria
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
Outcomes
Primary Outcomes
pregnancy rate
Time Frame: 3 years
time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery.
Secondary Outcomes
- Overall survival(5 years)
- disease free survival(5 years)