Clinical trial · Observational
Node Positive Cervical Cancer Treated by Neoadjuvant Chemotherapy Plus Radical Surgery: a Single Center Experience
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Retrospectively data collection complited
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| cervical biopsies/conization, | Procedure | — | UNRESOLVED |
| hysterectomy, salpingo-oophorectomy, and lymphadenectomy | Procedure | — | UNRESOLVED |
| imaging tests (TCTB, TC-PET, MRI) | Diagnostic Test | — | UNRESOLVED |
| neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2)
- description
- 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.
- interventionNames
- 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
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS) in Patients with Cervical Cancer After NACT + Radical Surgery
- timeFrame
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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+
References
Publications (1)
- DERIVEDPalaia 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. PMID 41958171