Clinical trial · Interventional
Feasibility Study: Conservative Treatment in Cervical Cancer
Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IB1 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conservative treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- conservative treatment in cervix cancer
- description
- we performed conservative treatment cervix cancer patients with IB FIGO stage without pelvic involvement
- interventionNames
- Procedure: conservative treatment
Primary outcomes (1)
- measure
- pregnancy rate
- timeFrame
- 3 years
- description
- time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery.
Secondary outcomes (2)
- measure
- disease free survival
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDRusso 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 34060027
- DERIVEDde 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 33092819