Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT06752135
Brief 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. 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:
NCT06752135
Study Brief:
Protocol Section:
NCT06752135