Clinical trial · Interventional
Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
NCT06867445CI-TRIAL-00092245MIPEXrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this clinical trial is to assess the oncologic safety of minimally invasive pelvic exenteration in patients with recurrence or persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). The primary aim is to assess the 3-year disease-free survival (DFS). The secondary aim is to assess the 3-year overall survival (OS), the intraoperative and post-operative complication rate, and the patient's quality of life.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Vaginal Cancers | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimally invasive pelvic exenteration | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Recruited patients
- description
- Cervical cancer or vaginal cancer patients with recurrent/persistent disease assessed for elegibility
- interventionNames
- Procedure: Minimally invasive pelvic exenteration
Primary outcomes (1)
- measure
- Disease free survival (DFS)
- timeFrame
- From the enrollment for the following three years.
- description
- The primary aim is to assess the 3-year disease free survival
Secondary outcomes (5)
- measure
- Overall survival (OS)
- timeFrame
- Survival time is calculated from the date of surgery until the date of death from any cause, or for patients still alive to the date of last clinical follow-up or contact, assessed up to 100 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of recurrent or persistent vaginal or cervical cancer * Proven histological diagnosis of squamous carcinoma, adenocarcinoma or adenosquamous carcinoma * Isolated central pelvic recurrence * MRI-measured maximum tumor diameter ≤ 50 mm * Age \> 18 years * Patients who have signed an approved informed consent form * Patients must be suitable for surgery * ECOG Performance Status of 0, 1 or 2 (Eastern Cooperative Oncology Group) Exclusion Criteria: * Para-aortic lymph nodes with a short-axis diameter ≥ 15 mm on MRI scan and/or SUV max ≥ 2.5 on PET/CT scan * Involvement of lateral pelvic structures (on preoperative imaging or during examination under anaesthesia) * Sciatic nerve involvement (at pre-operative imaging or during examination under anaesthesia) * Distant metastasis at PET/CT scan * Any histological type other than squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma * Contraindications to surgery * Serious concomitant systemic disorders incompatible with surgery or minimally invasive surgery (at the discretion of the investigator) * Women unable to tolerate prolonged lithotomy and steep Trendelenburg positions * Women with secondary invasive neoplasm in the last 5 years
References
Publications (8)
- BACKGROUNDMantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep. 1966 Mar;50(3):163-70. No abstract available. PMID 5910392
- BACKGROUNDKaplan EL, Meier P. Nonparametric estimation from incomplete observation. J Am Stat Assoc 1958;53:457-481
- BACKGROUNDSchmidt AM, Imesch P, Fink D, Egger H. Indications and long-term clinical outcomes in 282 patients with pelvic exenteration for advanced or recurrent cervical cancer. Gynecol Oncol. 2012 Jun;125(3):604-9. doi: 10.1016/j.ygyno.2012.03.001. Epub 2012 Mar 7. PMID 22406639
- BACKGROUNDGreimel ER, Kuljanic Vlasic K, Waldenstrom AC, Duric VM, Jensen PT, Singer S, Chie W, Nordin A, Bjelic Radisic V, Wydra D; European Organization for Research and Treatment of Cancer Quality-of-Life Group. The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module: EORTC QLQ-CX24. Cancer. 2006 Oct 15;107(8):1812-22. doi: 10.1002/cncr.22217. PMID 16977652
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDDindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. PMID 15273542
- BACKGROUNDBizzarri N, Chiantera V, Ercoli A, Fagotti A, Tortorella L, Conte C, Cappuccio S, Di Donna MC, Gallotta V, Scambia G, Vizzielli G. Minimally Invasive Pelvic Exenteration for Gynecologic Malignancies: A Multi-Institutional Case Series and Review of the Literature. J Minim Invasive Gynecol. 2019 Nov-Dec;26(7):1316-1326. doi: 10.1016/j.jmig.2018.12.019. Epub 2019 Jan 4.