Feasibility Study: Conservative Treatment in Cervical Cancer

Stage IB1 Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02323841
• Other study ID #: 12650/13
• Status: Active, not recruiting
• Phase: Phase 0
• First received: April 8, 2014
• Last updated: December 23, 2014
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2014
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators would like to be conservative in young patients affected by early stage cervical cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stage IB1 Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• conservative treatment
we performed pelvic lymphadenectomy before neoadjuvant chemotherapy and conization as conservative treatments

Locations

Country	Name	City	State
Italy	Giovanni Scambia	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate	time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery.	3 years	Yes
Secondary	disease free survival	time of disease free surviva	5 years	Yes
Secondary	Overall survival	Time to the last follow up/death	5 years	Yes