Node Positive Cervical Cancer Treated by Neoadjuvant Chemotherapy Plus Radical Surgery: a Single Center Experience

NCT06752135 | Terminated

• 2 other identifiers: AOU Umberto ICx - Prot.0330/2024|Rif. 7350
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Carcinoma

Keywords

cervical carcinoma; neoadjuvant chemotherapy.; observational study; retrospective; radiological prognostic factors; imaging methodologies; MRI; TC scan; PFS; OS; pathological parameters; radiological parameters; clinical parameters

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

Study Arms (1)

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.

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

Interventions

cervical biopsies/conization, PROCEDURE

Diagnostic laparoscopy was used in selected cases to evaluate potential peritoneal spread.

Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2)

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.

Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2)

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.

Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2)

hysterectomy, salpingo-oophorectomy, and lymphadenectomy PROCEDURE

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.

Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2)

brachytherapy RADIATION

alternative to cCRT-B.

Cervical squamous cell carcinoma or adenocarcinoma (FIGO IIIC1-2)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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+

Sponsors & Collaborators

• Azienda Policlinico Umberto I: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

AOU Policlinico Umberto I - Roma

Roma, 00161, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Conization; Magnetic Resonance Imaging; Neoadjuvant Therapy; Cisplatin; Carboplatin; Paclitaxel; Hysterectomy; Salpingo-oophorectomy; Lymph Node Excision; Brachytherapy

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Tomography; Diagnostic Imaging; Combined Modality Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Ovariectomy; Castration; Endocrine Surgical Procedures; Salpingectomy; Radiotherapy

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 30, 2024
• Study Start: April 10, 2024
• Primary Completion: August 8, 2024
• Study Completion: December 6, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

IT (1)