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Feasibility Study: Conservative Treatment in Cervical Cancer

NCT ID: NCT02323841

Last Updated: 2014-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-03-31

Brief Summary

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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

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

Conditions

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Stage IB1 Cervical Cancer

Keywords

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cervical cancer neoadjuvant chemotherapy Adverse Effects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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conservative treatment in cervix cancer

we performed conservative treatment cervix cancer patients with IB FIGO stage without pelvic involvement

Group Type EXPERIMENTAL

conservative treatment

Intervention Type PROCEDURE

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

Interventions

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conservative treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Prof. Giovanni Scambia

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanni Scambia, PhD

Role: STUDY_CHAIR

Catholic University of Sacred Heart

Locations

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Giovanni Scambia

Rome, Italy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 34060027 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33092819 (View on PubMed)

Other Identifiers

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12650/13

Identifier Type: -

Identifier Source: org_study_id