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Clinical Trials/NCT02323841
NCT02323841
Unknown
Early Phase 1

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

Catholic University of the Sacred Heart1 site in 1 country30 target enrollmentMarch 2014

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Stage IB1 Cervical Cancer
Sponsor
Catholic University of the Sacred Heart
Enrollment
30
Locations
1
Primary Endpoint
pregnancy rate
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
March 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Giovanni Scambia

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

Catholic University of the Sacred Heart

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

Outcomes

Primary Outcomes

pregnancy rate

Time Frame: 3 years

time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery.

Secondary Outcomes

  • Overall survival(5 years)
  • disease free survival(5 years)

Study Sites (1)

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