Feasibility Study: Conservative Treatment in Cervical Cancer
This trial is active, not recruiting.
|Condition||stage ib1 cervical cancer|
|Sponsor||Catholic University of the Sacred Heart|
|Start date||March 2014|
|End date||March 2014|
|Trial size||30 participants|
|Trial identifier||NCT02323841, 12650/13|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 3 years
disease free survival
time frame: 5 years
time frame: 5 years
Female participants from 18 years up to 40 years old.
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
|Official title||Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm|
|Description||The investigators would like to be conservative in young patients affected by early stage cervical cancer.|
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