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Feasibility Study: Conservative Treatment in Cervical Cancer

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02323841
Enrollment
30
Registered
2014-12-24
Start date
2014-03-31
Completion date
2015-03-31
Last updated
2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IB1 Cervical Cancer

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

PROCEDUREconservative treatment

we performed pelvic lymphadenectomy before neoadjuvant chemotherapy and conization as conservative treatments

Sponsors

Catholic University of the Sacred Heart
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

MeasureTime frameDescription
pregnancy rate3 yearstime of pregnancy. Case of miscarriage, pre-term delivery or full term delivery.

Secondary

MeasureTime frameDescription
disease free survival5 yearstime of disease free surviva
Overall survival5 yearsTime to the last follow up/death

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026