Feasibility Study: Conservative Treatment in Cervical Cancer

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

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

Conditions
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Stage IB1 Cervical Cancer

Intervention / Treatment
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* Procedure: conservative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conservative treatment in cervix cancer<br>we performed conservative treatment cervix cancer patients with IB FIGO stage without pelvic involvement | Procedure: conservative treatment<br>* we performed pelvic lymphadenectomy before neoadjuvant chemotherapy and conization as conservative treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | time of disease free surviva | 5 years | 
| Overall survival | Time to the last follow up/death | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, neoadjuvant chemotherapy, Adverse Effects