Cervical CarcinomaHRCC1NCT06752135
Node Positive Cervical Cancer Treated by Neoadjuvant Chemotherapy Plus Radical Surgery: a Single Center Experience
An observational study of Cervical Carcinoma, run by Azienda Policlinico Umberto I at 1 site in Italy.
Trial summary
This clinical study focuses on the treatment of high-risk locally advanced cervical cancer (LACC) in women with lymph node involvement (stages IIIC1 and IIIC2). Cervical cancer (CC) is a significant health concern worldwide, particularly for women, with high rates of diagnosis and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- cervical biopsies/conization,, imaging tests (TCTB, TC-PET, MRI) and neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel)
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2024to 6 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Study population consisted of women aged 18 years or older who attended the AOU Policlinico Umberto I and had been diagnosed with cervical cancer, specifically squamous cell carcinoma or adenocarcinoma. These women had imaging-confirmed positive lymph nodes, corresponding to FIGO stages IIIC1-2, indicating locally advanced disease. The patients were required to have an ECOG performance status 0-1, suggesting that they were in relatively good general health and able to tolerate treatment. Participants had no prior history of oncological treatments and were not pregnant at the time of enrollment. Eligible participants were expected to have a life expectancy of at least three months. Additionally, they needed to be capable of understanding the study and willing to provide written informed consent. Patients with distant metastases or other concomitant malignancies were excluded, as were those with conditions that could complicate treatment, such as systemic diseases, immunodeficiencies.
Who may be able to join
- Women aged ≥ 18 years attending the AOU Policlinico Umberto I
- histological diagnosis of cervical squamous cell carcinoma or adenocarcinoma; presence of positive lymph nodes at imaging (FIGO IIIC1-2 stage);
- ECOG performance status 0 or 1;
- No previous oncological treatments;
- No actual pregnancy;
- Life expectancy of at least 3 months;
- Ability to understand and willingness of the subject to participate in the trial confirmed by the signature of the written informed consent.
- No of distant metastasis or concomitant neoplasms.
Who cannot join
- Patients who have a clinical diagnosis different from advanced cervical cancer stages IB2-IVA
- Patients who have not received neoadjuvant chemotherapy
- Systemic diseases or immunodeficiencies
- Patients who are HCV+, HBV+, or HIV+
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study focuses on the treatment of high-risk locally advanced cervical cancer (LACC) in women with lymph node involvement (stages IIIC1 and IIIC2). Cervical cancer (CC) is a significant health concern worldwide, particularly for women, with high rates of diagnosis and mortality. While there have been advances in prevention and treatment, a substantial number of patients are still diagnosed with advanced-stage disease, which often involves cancer spread to nearby lymph nodes.
In standard practice, patients with LACC are usually treated with chemoradiation plus brachytherapy (cCRT-B). However, this approach can have considerable side effects and doesn't always provide a long-term cure. The study explores an alternative treatment regimen involving neoadjuvant chemotherapy (NACT) followed by radical surgery (RS) to evaluate its potential in improving survival outcomes and reducing recurrence. Neoadjuvant chemotherapy, a treatment given before surgery to shrink tumors, is often used for different types of cancer, and this study examines its benefits in cervical cancer patients with nodal involvement.
Read more
The main goal of this study is to determine whether NACT combined with radical surgery can offer survival rates and progression-free survival comparable to the standard treatment of chemoradiation. Additionally, the study aims to assess patterns of recurrence after treatment and to explore how these patients responded to further treatment options.
Study hypotheses: NACT + RS as a viable alternative: The hypothesis is that the combination of NACT followed by radical surgery may lead to survival outcomes comparable to those achieved by the standard cCRT-B treatment, particularly in patients with node-positive cervical cancer.
Improved recurrence management: Another key hypothesis is that the recurrence patterns in patients treated with NACT + RS are different, and a significant proportion of recurrent cases may be treated successfully with curative approaches such as surgery or radiotherapy.
Quality of life considerations: This treatment approach may offer better quality of life compared to chemoradiation by avoiding some of the severe side effects of radiotherapy, such as vaginal stenosis and other complications.
The study follows 97 patients who were treated at the Gynecologic Oncology Unit of Policlinico Umberto I, Sapienza University of Rome, between 2012 and 2022. The patients were diagnosed with cervical cancer and were in stages IIIC1 or IIIC2, meaning they had lymph node involvement. These patients received three cycles of chemotherapy (cisplatin and paclitaxel) followed by radical surgery, with further treatment depending on the surgical outcomes. After surgery, patients underwent a follow-up program to monitor for disease recurrence and overall survival.
Read the detailed description
This study is a retrospective observational investigation aimed at evaluating the treatment outcomes of neoadjuvant chemotherapy (NACT) followed by radical surgery (RS) in patients with high-risk locally advanced cervical cancer (LACC) exhibiting positive lymph nodes (FIGO IIIC1-2 stage). The study analyzes recurrence patterns, subsequent treatments, and survival outcomes in a cohort of patients treated over a 10-year period at the Gynecologic Oncology Unit of Policlinico Umberto I, Sapienza University of Rome.
Study objectives and hypotheses: the primary hypothesis of this study is that the combination of NACT and radical surgery can offer survival outcomes and patterns of recurrence comparable to the standard chemoradiotherapy (cCRT-B) for LACC patients with nodal involvement (FIGO IIIC1-2). The secondary hypothesis suggests that a significant proportion of patients with recurrent disease can benefit from curative interventions (surgery, chemotherapy, or chemoradiotherapy), improving overall survival (OS) and progression-free survival (PFS) rates.
Study design and methodology: this study involved 97 patients diagnosed with locally advanced cervical cancer, all treated with NACT followed by RS from January 2012 to December 2022. The study's inclusion criteria were: patients aged 18-75 years with histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, positive lymph nodes (FIGO IIIC1-2), and no prior oncological treatments. The treatment protocol involved three cycles of platinum-based NACT (cisplatin or carboplatin plus paclitaxel), followed by imaging assessments to evaluate the response to chemotherapy. Only patients with complete or partial responses according to RECIST criteria were considered for subsequent radical surgery.
The study also assessed the pattern of recurrence, treatments for recurrence, and survival outcomes, with data collection including clinical examination, imaging (CT, MRI, PET-CT), and histopathological analyses. The main measures of success were OS and PFS, with statistical analyses conducted using Kaplan-Meier methods.
Quality assurance and data management: the study adhered to a rigorous quality assurance plan that ensured accurate data collection, validation, and analysis. Data were sourced from an institutional database and reviewed by an expert panel. To ensure consistency, data were cross-verified with external sources such as medical records, and discrepancies were resolved through audit procedures. A detailed data dictionary was maintained to ensure consistency in variable definitions, coding (e.g., WHO drug dictionary), and reporting standards.
Atatistical analysis: the statistical analysis involved the Fisher exact test for categorical data, t-tests for parametric continuous variables, and the Mann-Whitney U test for non-parametric data. Survival data were analyzed using the Kaplan-Meier method, estimating OS and PFS for all patients and subgroups, including comparisons based on FIGO stage IIIC1 versus IIIC2. Survival outcomes were also analyzed in relation to the recurrence sites (e.g., pelvic nodes, central pelvis).
- Conditions
- Cervical Carcinoma
- Being tested
- cervical biopsies/conization,, imaging tests (TCTB, TC-PET, MRI), neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel), hysterectomy, salpingo-oophorectomy, and lymphadenectomy, brachytherapy
- Keywords
- cervical carcinoma, neoadjuvant chemotherapy., observational study, retrospective, radiological prognostic factors, imaging methodologies, MRI, TC scan, PFS, OS, pathological parameters, radiological parameters, clinical parameters
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical biopsies/conization,Procedure or surgery
Diagnostic laparoscopy was used in selected cases to evaluate potential peritoneal spread.
imaging tests (TCTB, TC-PET, MRI)Diagnostic test
The staging procedures included imaging such as chest CT, abdomino-pelvic MRI, and PET-CT to assess tumor spread and lymph node involvement.
neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel)Drug
Patients received three cycles of platinum-based neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel), followed by imaging to assess treatment response.
hysterectomy, salpingo-oophorectomy, and lymphadenectomyProcedure or surgery
Eligible patients underwent radical surgery, including hysterectomy, salpingo-oophorectomy, and lymphadenectomy, with adjuvant therapy administered as needed based on surgical findings. Follow-up included regular clinical exams, imaging, and tests to monitor for recurrence.
brachytherapyRadiation
alternative to cCRT-B.
| Study group | Role | What they receive |
|---|---|---|
| Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2) | The study cohort included women aged 18-75 years with histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, positive lymph nodes (FIGO IIIC1-2), no prior oncological treatments, no pregnancy, a performance status of 0-2 (WHO), life expectancy of at least 3 months, and no evidence of distant metastasis or concomitant cancers. Receives: Procedure: cervical biopsies/conization,; Diagnostic Test: imaging tests (TCTB, TC-PET, MRI); Drug: neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel); Procedure: hysterectomy, salpingo-oophorectomy, and lymphadenectomy; Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) in Patients with Cervical Cancer After NACT + Radical Surgery
Progression-Free Survival (PFS) was measured as the proportion of patients surviving without death from any cause. Progression-Free Survival (PFS) was measured as the proportion of patients without disease progression after the treatment. Metrics were calculated for the entire cohort and by FIGO stage (IIIC1 and IIIC2). The survival analysis was performed using Kaplan-Meier estimation, and survival curves were presented for PFS. These outcomes were analyzed to assess the long-term effectiveness of NACT followed by radical surgery in cervical cancer patients.
Measured: Progression-Free Survival (PFS) were assessed at 2 years and 5 years after the treatment completion, with follow-up assessments conducted regularly every 3 months for the first 2 years and then every 6 months until the 5th years
Overall Survival (OS) in Patients with Cervical Cancer After NACT + Radical Surgery
Overall Survival (OS) was measured as the proportion of patients surviving. Metrics were calculated for the entire cohort and by FIGO stage (IIIC1 and IIIC2). The survival analysis was performed using Kaplan-Meier estimation, and survival curves were presented for OS. These outcomes were analyzed to assess the long-term effectiveness of NACT followed by radical surgery in cervical cancer patients.
Measured: Overall Survival (OS) were assessed at 2 years and 5 years after the treatment completion, with follow-up assessments conducted regularly every 3 months for the first 2 years and then every 6 months until the 5th years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start10 Apr 2024
- Primary completion8 Aug 2024
- Study completion6 Dec 2024
Why it stopped: Retrospectively data collection complited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Innocenza Palaia, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752135
- Sponsor's protocol ID
- AOU Umberto I
- Other IDs
- Cx - Prot.0330/2024|Rif. 7350
- Acronym
- HRCC1
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Palaia I, Perniola G, Tonti N, Tomao F, Pernazza A, Barchiesi G, Manganaro L, De Felice F, Musella A, Paoni Saccone G, Tanzi F, Mancini S, Vestri A, Alunni Fegatelli D, Benedetti Panici P, Muzii L, Di Donato V. Outcomes of node-positive cervical cancer treated with neoadjuvant chemotherapy followed by radical surgery: a single-center approach to a challenging disease. J Gynecol Oncol. 2026 Mar 30. doi: 10.3802/jgo.2026.37.e87. Online ahead of print.
PubMed 41958171
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Node Positive Cervical Cancer Treated by Neoadjuvant Chemotherapy Plus Radical Surgery: a Single Center Experience
- ClinicalTrials.gov ID
- NCT06752135
- Acronym / sponsor ID
- HRCC1 / AOU Umberto I
- Conditions
- Cervical Carcinoma
- Keywords
- cervical carcinoma, neoadjuvant chemotherapy., observational study, retrospective, radiological prognostic factors, imaging methodologies, MRI, TC scan
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Retrospectively data collection complited
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 30 Dec 2024 (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.
This clinical study focuses on the treatment of high-risk locally advanced cervical cancer (LACC) in women with lymph node involvement (stages IIIC1 and IIIC2). Cervical cancer (CC) is a significant health concern worldwide, particularly for women, with high rates of diagnosis and mortality. While there have been advances in prevention and treatment, a substantial number of patients are still diagnosed with advanced-stage disease, which often involves cancer spread to nearby lymph nodes.
In standard practice, patients with LACC are usually treated with chemoradiation plus brachytherapy (cCRT-B). However, this approach can have considerable side effects and doesn't always provide a long-term cure. The study explores an alternative treatment regimen involving neoadjuvant chemotherapy (NACT) followed by radical surgery (RS) to evaluate its potential in improving survival outcomes and reducing recurrence. Neoadjuvant chemotherapy, a treatment given before surgery to shrink tumors, is often used for different types of cancer, and this study examines its benefits in cervical cancer patients with nodal involvement.
The main goal of this study is to determine whether NACT combined with radical surgery can offer survival rates and progression-free survival comparable to the standard treatment of chemoradiation. Additionally, the study aims to assess patterns of recurrence after treatment and to explore how these patients responded to further treatment options.
Study hypotheses: NACT + RS as a viable alternative: The hypothesis is that the combination of NACT followed by radical surgery may lead to survival outcomes comparable to those achieved by the standard cCRT-B treatment, particularly in patients with node-positive cervical cancer.
Improved recurrence management: Another key hypothesis is that the recurrence patterns in patients treated with NACT + RS are different, and a significant proportion of recurrent cases may be treated successfully with curative approaches such as surgery or radiotherapy.
Quality of life considerations: This treatment approach may offer better quality of life compared to chemoradiation by avoiding some of the severe side effects of radiotherapy, such as vaginal stenosis and other complications.
The study follows 97 patients who were treated at the Gynecologic Oncology Unit of Policlinico Umberto I, Sapienza University of Rome, between 2012 and 2022. The patients were diagnosed with cervical cancer and were in stages IIIC1 or IIIC2, meaning they had lymph node involvement. These patients received three cycles of chemotherapy (cisplatin and paclitaxel) followed by radical surgery, with further treatment depending on the surgical outcomes. After surgery, patients underwent a follow-up program to monitor for disease recurrence and overall survival.
Detailed description
This study is a retrospective observational investigation aimed at evaluating the treatment outcomes of neoadjuvant chemotherapy (NACT) followed by radical surgery (RS) in patients with high-risk locally advanced cervical cancer (LACC) exhibiting positive lymph nodes (FIGO IIIC1-2 stage). The study analyzes recurrence patterns, subsequent treatments, and survival outcomes in a cohort of patients treated over a 10-year period at the Gynecologic Oncology Unit of Policlinico Umberto I, Sapienza University of Rome.
Study objectives and hypotheses: the primary hypothesis of this study is that the combination of NACT and radical surgery can offer survival outcomes and patterns of recurrence comparable to the standard chemoradiotherapy (cCRT-B) for LACC patients with nodal involvement (FIGO IIIC1-2). The secondary hypothesis suggests that a significant proportion of patients with recurrent disease can benefit from curative interventions (surgery, chemotherapy, or chemoradiotherapy), improving overall survival (OS) and progression-free survival (PFS) rates.
Study design and methodology: this study involved 97 patients diagnosed with locally advanced cervical cancer, all treated with NACT followed by RS from January 2012 to December 2022. The study's inclusion criteria were: patients aged 18-75 years with histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, positive lymph nodes (FIGO IIIC1-2), and no prior oncological treatments. The treatment protocol involved three cycles of platinum-based NACT (cisplatin or carboplatin plus paclitaxel), followed by imaging assessments to evaluate the response to chemotherapy. Only patients with complete or partial responses according to RECIST criteria were considered for subsequent radical surgery.
The study also assessed the pattern of recurrence, treatments for recurrence, and survival outcomes, with data collection including clinical examination, imaging (CT, MRI, PET-CT), and histopathological analyses. The main measures of success were OS and PFS, with statistical analyses conducted using Kaplan-Meier methods.
Quality assurance and data management: the study adhered to a rigorous quality assurance plan that ensured accurate data collection, validation, and analysis. Data were sourced from an institutional database and reviewed by an expert panel. To ensure consistency, data were cross-verified with external sources such as medical records, and discrepancies were resolved through audit procedures. A detailed data dictionary was maintained to ensure consistency in variable definitions, coding (e.g., WHO drug dictionary), and reporting standards.
Atatistical analysis: the statistical analysis involved the Fisher exact test for categorical data, t-tests for parametric continuous variables, and the Mann-Whitney U test for non-parametric data. Survival data were analyzed using the Kaplan-Meier method, estimating OS and PFS for all patients and subgroups, including comparisons based on FIGO stage IIIC1 versus IIIC2. Survival outcomes were also analyzed in relation to the recurrence sites (e.g., pelvic nodes, central pelvis).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2) | – | Procedure: cervical biopsies/conization,, Diagnostic Test: imaging tests (TCTB, TC-PET, MRI), Drug: neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel), Procedure: hysterectomy, salpingo-oophorectomy, and lymphadenectomy, Radiation: brachytherapyThe study cohort included women aged 18-75 years with histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, positive lymph nodes (FIGO IIIC1-2), no prior oncological treatments, no pregnancy, a performance status of 0-2 (WHO), life expectancy of at least 3 months, and no evidence of distant metastasis or concomitant cancers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consisted of women aged 18 years or older who attended the AOU Policlinico Umberto I and had been diagnosed with cervical cancer, specifically squamous cell carcinoma or adenocarcinoma. These women had imaging-confirmed positive lymph nodes, corresponding to FIGO stages IIIC1-2, indicating locally advanced disease. The patients were required to have an ECOG performance status 0-1, suggesting that they were in relatively good general health and able to tolerate treatment. Participants had no prior history of oncological treatments and were not pregnant at the time of enrollment. Eligible participants were expected to have a life expectancy of at least three months. Additionally, they needed to be capable of understanding the study and willing to provide written informed consent. Patients with distant metastases or other concomitant malignancies were excluded, as were those with conditions that could complicate treatment, such as systemic diseases, immunodeficiencies.
Key inclusion criteria (8 listed)
- Women aged ≥ 18 years attending the AOU Policlinico Umberto I
- histological diagnosis of cervical squamous cell carcinoma or adenocarcinoma; presence of positive lymph nodes at imaging (FIGO IIIC1-2 stage);
- ECOG performance status 0 or 1;
- No previous oncological treatments;
- No actual pregnancy;
Key exclusion criteria (4 listed)
- Patients who have a clinical diagnosis different from advanced cervical cancer stages IB2-IVA
- Patients who have not received neoadjuvant chemotherapy
- Systemic diseases or immunodeficiencies
- Patients who are HCV+, HBV+, or HIV+
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 |
|---|---|---|
| cervical biopsies/conization,Diagnostic laparoscopy was used in selected cases to evaluate potential peritoneal spread. | Procedure or surgery | Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2) |
| imaging tests (TCTB, TC-PET, MRI)The staging procedures included imaging such as chest CT, abdomino-pelvic MRI, and PET-CT to assess tumor spread and lymph node involvement. | Diagnostic test | Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2) |
| neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel)Patients received three cycles of platinum-based neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel), followed by imaging to assess treatment response. | Drug | Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2) |
| hysterectomy, salpingo-oophorectomy, and lymphadenectomyEligible patients underwent radical surgery, including hysterectomy, salpingo-oophorectomy, and lymphadenectomy, with adjuvant therapy administered as needed based on surgical findings. Follow-up included regular clinical exams, imaging, and tests to monitor for recurrence. | Procedure or surgery | Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2) |
| brachytherapyalternative to cCRT-B. | Radiation | Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2) |
Primary outcome
Progression-Free Survival (PFS) in Patients with Cervical Cancer After NACT + Radical Surgery
Time frame: Progression-Free Survival (PFS) were assessed at 2 years and 5 years after the treatment completion, with follow-up assessments conducted regularly every 3 months for the first 2 years and then every 6 months until the 5th years
Progression-Free Survival (PFS) was measured as the proportion of patients surviving without death from any cause. Progression-Free Survival (PFS) was measured as the proportion of patients without disease progression after the treatment. Metrics were calculated for the entire cohort and by FIGO stage (IIIC1 and IIIC2). The survival analysis was performed using Kaplan-Meier estimation, and survival curves were presented for PFS. These outcomes were analyzed to assess the long-term effectiveness of NACT followed by radical surgery in cervical cancer patients.
Overall Survival (OS) in Patients with Cervical Cancer After NACT + Radical Surgery
Time frame: Overall Survival (OS) were assessed at 2 years and 5 years after the treatment completion, with follow-up assessments conducted regularly every 3 months for the first 2 years and then every 6 months until the 5th years
Overall Survival (OS) was measured as the proportion of patients surviving. Metrics were calculated for the entire cohort and by FIGO stage (IIIC1 and IIIC2). The survival analysis was performed using Kaplan-Meier estimation, and survival curves were presented for OS. These outcomes were analyzed to assess the long-term effectiveness of NACT followed by radical surgery in cervical cancer patients.
Results and safety
The study was stopped early (reason given: Retrospectively data collection complited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Derived from this study: PubMed 41958171Palaia I, Perniola G, Tonti N, Tomao F, Pernazza A, Barchiesi G, Manganaro L, De Felice F, Musella A, Paoni Saccone G, Tanzi F, Mancini S, Vestri A, Alunni Fegatelli D, Benedetti Panici P, Muzii L, Di Donato V. Outcomes of node-positive cervical cancer treated with neoadjuvant chemotherapy followed by radical surgery: a single-center approach to a challenging disease. J Gynecol Oncol. 2026 Mar 30. doi: 10.3802/jgo.2026.37.e87. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Carcinoma, run by Azienda Policlinico Umberto I 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 4 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: stopped early, as of the sponsor's last update on 30 Dec 2024. 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?
The study was stopped early (reason given: Retrospectively data collection complited). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) in Patients with Cervical Cancer After NACT + Radical Surgery (time frame: Progression-Free Survival (PFS) were assessed at 2 years and 5 years after the treatment completion, with follow-up assessments conducted regularly every 3 months for the first 2 years and then every 6 months until the 5th years). The study lists 2 primary outcomes in all. 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 NCT06752135, which also lists 1 linked publication.
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 30 Dec 2024.