This trial is active, not recruiting.

Condition stage ib1 cervical cancer
Treatment conservative treatment
Phase phase 0
Sponsor Catholic University of the Sacred Heart
Start date March 2014
End date March 2014
Trial size 30 participants
Trial identifier NCT02323841, 12650/13


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
we performed conservative treatment cervix cancer patients with IB FIGO stage without pelvic involvement
conservative treatment
we performed pelvic lymphadenectomy before neoadjuvant chemotherapy and conization as conservative treatments

Primary Outcomes

pregnancy rate
time frame: 3 years

Secondary Outcomes

disease free survival
time frame: 5 years
Overall survival
time frame: 5 years

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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

Additional Information

Official title Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm
Description The investigators would like to be conservative in young patients affected by early stage cervical cancer.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Catholic University of the Sacred Heart.