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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.
The investigators would like to be conservative in young patients affected by early stage cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conservative treatment in cervix cancer | Experimental | we performed conservative treatment cervix cancer patients with IB FIGO stage without pelvic involvement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conservative treatment | Procedure | we performed pelvic lymphadenectomy before neoadjuvant chemotherapy and conization as conservative treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate | time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery. | 3 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Scambia, PhD | Catholic University of Sacred Heart | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Giovanni Scambia | Rome | Italy | 00135 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34060027 | Derived | Russo L, Gui B, Micco M, Panico C, De Vincenzo R, Fanfani F, Scambia G, Manfredi R. The role of MRI in cervical cancer > 2 cm (FIGO stage IB2-IIA1) conservatively treated with neoadjuvant chemotherapy followed by conization: a pilot study. Radiol Med. 2021 Aug;126(8):1055-1063. doi: 10.1007/s11547-021-01377-1. Epub 2021 May 31. | |
| 33092819 |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| de Vincenzo R, Ricci C, Fanfani F, Gui B, Gallotta V, Fagotti A, Ferrandina G, Scambia G. Neoadjuvant chemotherapy followed by conization in stage IB2-IIA1 cervical cancer larger than 2 cm: a pilot study. Fertil Steril. 2021 Jan;115(1):148-156. doi: 10.1016/j.fertnstert.2020.07.006. Epub 2020 Oct 20. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |