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

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

Interventions

PROCEDURE

cervical biopsies/conization,

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

DIAGNOSTIC_TEST

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.

DRUG

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.

PROCEDURE

hysterectomy, salpingo-oophorectomy, and lymphadenectomy

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.

RADIATION

brachytherapy

alternative to cCRT-B.

Sponsors & Collaborators

• University of Roma La Sapienza

  collaborator OTHER

• Azienda Policlinico Umberto I

  lead OTHER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-10

Primary Completion

2024-08-08

Completion

2024-12-06

Countries

• Italy

Study Locations