NCT02323841

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 24, 2014

Status Verified

February 1, 2014

Enrollment Period

Same day

First QC Date

April 8, 2014

Last Update Submit

December 23, 2014

Conditions

Stage IB1 Cervical Cancer

Keywords

cervical cancerneoadjuvant chemotherapyAdverse Effects

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

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

    3 years

Secondary Outcomes (2)

  • disease free survival

    5 years

  • Overall survival

    5 years

Study Arms (1)

conservative treatment in cervix cancer

EXPERIMENTAL

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

Procedure: conservative treatment

Interventions

conservative treatmentPROCEDURE

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

conservative treatment in cervix cancer

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • ongoing pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giovanni Scambia

Rome, Italy, 00135, Italy

Location

Related Publications (2)

  • 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.

    PMID: 34060027DERIVED

  • 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.

    PMID: 33092819DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Giovanni Scambia, PhD

    Catholic University of Sacred Heart

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm

Study Record Dates

First Submitted

April 8, 2014

First Posted

December 24, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

December 24, 2014

Record last verified: 2014-02

Locations

IT(1)