Stage IB1 Cervical Cancer
Conditions
Keywords
cervical cancer, neoadjuvant chemotherapy, Adverse Effects
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.
Interventions
we performed pelvic lymphadenectomy before neoadjuvant chemotherapy and conization as conservative treatments
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy rate | 3 years | time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease free survival | 5 years | time of disease free surviva |
| Overall survival | 5 years | Time to the last follow up/death |
Countries
Italy