Clinical trial NCT02323841: Feasibility Study: Conservative Treatment in Cervical Cancer
Official title: Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Stage IB1 Cervical Cancer
Keywords: cervical cancer
neoadjuvant chemotherapy
Adverse Effects
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: pregnancy rate
timeFrame: 3 years
Secondary outcomes:
measure: disease free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Giovanni Scambia
Study officials:
affiliation: Catholic University of Sacred Heart
name: Giovanni Scambia, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.