Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence

NCT06867445 | Recruiting

• 1 other identifier: ID 7338
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervical Cancers; Vaginal Cancers

Keywords

cervical cancer; vaginal cancer; minimally invasive surgery; pelvic exenteration; gynecologic oncology

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS)

  The primary aim is to assess the 3-year disease free survival

  From the enrollment for the following three years.

Secondary Outcomes (5)

• Overall survival (OS)

  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.

• Intraoperative complication rate

  During the procedure

• Post-operative complication rate

  One month and six months after surgery

• Health Related Quality of Life (HRQoL) n.1

  At baseline and one month, six months, one years and two years after surgery.

• Health Related Quality of Life (HRQoL) n. 2

  At baseline and one month, six months, one years and two years after surgery.

Study Arms (1)

Recruited patients

EXPERIMENTAL

Cervical cancer or vaginal cancer patients with recurrent/persistent disease assessed for elegibility

Procedure: Minimally invasive pelvic exenteration

Interventions

Minimally invasive pelvic exenteration PROCEDURE

If all criteria are met, patients are registered. The patient is enrolled before the surgery, at the time of pelvic evaluation under anaesthesia. A diagnostic laparoscopic assessment can be performed before the operation to exclude peritoneal metastasis. The experimental procedure in this protocol involves the use of a minimally invasive approach (robot-assisted or laparoscopic) for performing pelvic exenteration.

Recruited patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients with cervical or vaginal cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Agostino Gemelli IRCCS

Rome, Italy

RECRUITING

Related Publications (8)

• Mantel 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 BACKGROUND

• Kaplan EL, Meier P. Nonparametric estimation from incomplete observation. J Am Stat Assoc 1958;53:457-481

  BACKGROUND

• Schmidt 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 BACKGROUND

• Greimel 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 BACKGROUND

• Aaronson 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 BACKGROUND

• Dindo 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 BACKGROUND

• Bizzarri 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.

  PMID: 30611973 BACKGROUND

• Sardain H, Lavoue V, Redpath M, Bertheuil N, Foucher F, Leveque J. Curative pelvic exenteration for recurrent cervical carcinoma in the era of concurrent chemotherapy and radiation therapy. A systematic review. Eur J Surg Oncol. 2015 Aug;41(8):975-85. doi: 10.1016/j.ejso.2015.03.235. Epub 2015 Apr 14.

  PMID: 25922209 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vaginal Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases

Study Officials

• Giovanni Scambia, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  STUDY DIRECTOR

Central Study Contacts

Nicolò Bizzarri

CONTACT

0630156249; nicolo.bizzarri@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor in the Gynecologic Oncology Department

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 10, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2031
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

IT (1)