Cervical CancersMIPEXNCT06867445
Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
A study testing Minimally invasive pelvic exenteration in people with Cervical Cancers and Vaginal Cancers, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancers, Vaginal Cancers
- What is being tested?
- Minimally invasive pelvic exenteration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jul 2025to 1 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Agostino Gemelli IRCCS
Rome
Nicolò Bizzarri, 0630156249, nicolo.bizzarri@policlinicogemelli.it
Nicolò Bizzarri
About this study
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.
Read the detailed description
Patients will be considered pre-operatively eligible in case of recurrence/persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). Histological diagnosis of recurrent or persistent disease obtained with biopsy performed during examination under anesthesia or US-guided biopsy, or RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria of progressive disease are required, as by standard clinical practice. All patients will undergo MRI pelvic scan and PET/CT scan within one month before the surgery, as by standard clinical practice. After obtaining oral and written informed consent, patients will be registered. Pelvic exenteration will be performed with the aim of removing a single specimen with negative surgical margins.
A mini-laparotomy of up to 7 cm will be allowed to complete the reconstructive phase of the procedure.
Registration data has to be entered to an electronic Case Report Form (eCRF). The Principal Investigator (PI) of the study will independently take responsibility for the development of an electronic Case Report Form (CRF) for data collection.
- Conditions
- Cervical Cancers, Vaginal Cancers
- Being tested
- Minimally invasive pelvic exenteration
- Keywords
- cervical cancer, vaginal cancer, minimally invasive surgery, pelvic exenteration, gynecologic oncology
- Medical subject headings
- Uterine Cervical Neoplasms, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive pelvic exenterationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Recruited patients | Experimental | Cervical cancer or vaginal cancer patients with recurrent/persistent disease assessed for elegibility Receives: Procedure: Minimally invasive pelvic exenteration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
The primary aim is to assess the 3-year disease free survival
Measured: From the enrollment for the following three years.
Secondary outcomes (5)
Overall survival (OS)
One of the secondary aim is to assess the overall survival.
Measured: 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
Intraoperative complications will be assessed with CTCAE 5.0 classification (Common Terminology Criteria for Adverse Events).
Measured: During the procedure
Post-operative complication rate
Post-operative complications: will be assessed with Clavien-Dindo classification
Measured: One month and six months after surgery
Health Related Quality of Life (HRQoL) n.1
Quality of life will be assessed by questionnaires completed by study participants preferably as electronical patient reported outcome measures or during the clinic visit.
Questionnaire n. 1 comprises the EORTC QLQ-30 (version 3.0, EORTC: European Organization for Research and Treatment of Cancer; QLQ: Quality-of-Life questionnaire).
Measured: At baseline and one month, six months, one years and two years after surgery.
Health Related Quality of Life (HRQoL) n. 2
Quality of life will be assessed by questionnaires completed by study participants preferably as electronical patient reported outcome measures or during the clinic visit.
Questionnaire n. 2 comprises the EORTC QLQCX24 (European Organization for Research and Treatment of Cancer; QLQ: Quality-of-Life questionnaire)
Measured: At baseline and one month, six months, one years and two years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start7 Jul 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bizzarri Nicolò, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Giovanni Scambia, MD, PhD, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867445
- Sponsor's protocol ID
- ID 7338
- Acronym
- MIPEX
- Status last verified
- Jul 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 5910392Kaplan EL, Meier P. Nonparametric estimation from incomplete observation. J Am Stat Assoc 1958;53:457-481
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.
PubMed 22406639Greimel 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.
PubMed 16977652Aaronson 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.
PubMed 8433390Dindo 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.
PubMed 15273542Bizzarri 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.
PubMed 30611973Sardain 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.
PubMed 25922209
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
- ClinicalTrials.gov ID
- NCT06867445
- Acronym / sponsor ID
- MIPEX / ID 7338
- Conditions
- Cervical Cancers, Vaginal Cancers
- Keywords
- cervical cancer, vaginal cancer, minimally invasive surgery, pelvic exenteration, gynecologic oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be considered pre-operatively eligible in case of recurrence/persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). Histological diagnosis of recurrent or persistent disease obtained with biopsy performed during examination under anesthesia or US-guided biopsy, or RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria of progressive disease are required, as by standard clinical practice. All patients will undergo MRI pelvic scan and PET/CT scan within one month before the surgery, as by standard clinical practice. After obtaining oral and written informed consent, patients will be registered. Pelvic exenteration will be performed with the aim of removing a single specimen with negative surgical margins.
A mini-laparotomy of up to 7 cm will be allowed to complete the reconstructive phase of the procedure.
Registration data has to be entered to an electronic Case Report Form (eCRF). The Principal Investigator (PI) of the study will independently take responsibility for the development of an electronic Case Report Form (CRF) for data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recruited patients | Experimental | Procedure: Minimally invasive pelvic exenterationCervical cancer or vaginal cancer patients with recurrent/persistent disease assessed for elegibility |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive pelvic exenterationIf 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. | Procedure or surgery | Recruited patients |
Primary outcome
Disease free survival (DFS)
Time frame: From the enrollment for the following three years.
The primary aim is to assess the 3-year disease free survival
5 secondary outcomes
Overall survival (OS)
Time frame: 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
Time frame: During the procedure
Post-operative complication rate
Time frame: One month and six months after surgery
Health Related Quality of Life (HRQoL) n.1
Time frame: At baseline and one month, six months, one years and two years after surgery.
Health Related Quality of Life (HRQoL) n. 2
Time frame: At baseline and one month, six months, one years and two years after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 5910392Mantel 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.
- BackgroundKaplan EL, Meier P. Nonparametric estimation from incomplete observation. J Am Stat Assoc 1958;53:457-481
- Background: PubMed 22406639Schmidt 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.
- Background: PubMed 16977652Greimel 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.
- Background: PubMed 8433390Aaronson 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.
- Background: PubMed 15273542Dindo 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.
- Background: PubMed 30611973Bizzarri 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.
- Background: PubMed 25922209Sardain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Scambia, MD, PhD study director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive pelvic exenteration in people with Cervical Cancers and Vaginal Cancers, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolò Bizzarri (0630156249, nicolo.bizzarri@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: From the enrollment for the following three years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867445, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.