Home › Trials › NCT05581121

Surgery followed by tailored treatment for advanced cervical cancer

PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

PHASE3 · Institut Claudius Regaud · NCT05581121

This study is testing whether surgery followed by personalized treatment can help women with advanced cervical cancer live longer and healthier compared to standard treatment alone.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment510 (estimated)
Ages18 Years and up
SexFemale
SponsorInstitut Claudius Regaud (other)
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations34 sites (Pilsen and 33 other locations)
Trial IDNCT05581121 on ClinicalTrials.gov

What this trial studies

This international, multicenter, randomized open-label phase III study aims to evaluate the effectiveness of para-aortic lymphadenectomy followed by tailored chemoradiation in patients with stage IIIC1 cervical cancer. Participants will be randomly assigned to either a control arm receiving standard chemoradiotherapy or an experimental arm undergoing the surgical procedure before treatment. The study plans to enroll 510 patients, with a significant portion from France, and will follow participants for five years to assess disease-free survival rates. Additionally, a cost-utility analysis will be conducted for patients in France to evaluate the economic impact of the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed stage IIIC1 cervical cancer and specific imaging results indicating positive pelvic nodes.

Not a fit: Patients who have undergone radical hysterectomy or have FDG-negative common iliac or para-aortic lymph nodes will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved disease-free survival rates for patients with advanced cervical cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with advanced cervical cancer.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 18 years at time of study entry
2. Newly diagnosed histologically proven cervical squamous carcinoma, adenocarcinoma, or adenosquamous tumor
3. FIGO stage IIIC1 (FIGO 2018) cervical cancer with FDG-PET/CT showing FDG-positive pelvic nodes and FDG-negative PALN including equivocal lymph nodes in the common iliac and para-aortic regions. The highest positive lymph node must be located inferior to the common iliac bifurcation in both sides (anatomical level 1).
4. Patients with TNM T stage I-IIIB.
5. FIGO stage IIIC1 cervical cancer by positive pelvic sentinel lymph node from surgical staging (either intraoperative assessment (frozen section) or from final histology - patients are not eligible after radical hysterectomy, and FDG-negative common iliac of para-aortic lymph node on PET/CT (performed before or after SLN procedure)
6. Patient eligible for pelvic radiotherapy and cisplatin-based chemotherapy with a curative intent as confirmed by a multidisciplinary board
7. ECOG performance status \< 2 i.e. 0 or 1
8. Life expectancy more than 12 months
9. Pretherapeutic imaging FDG-PET/CT images should be available for central review
10. Prior validation of the surgeon's participation in the study by the Quality Assurance Comity
11. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to study entry.
12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
13. Not applicable since protocol revision V4. Patient participating to other clinical trials including immunotherapy strategies or adjuvant chemotherapy is also eligible for the study. Adjuvant treatment must be decided prior to randomization
14. Signed informed consent
15. Patient affiliated to a Social Health Insurance in France (French patients only).

Exclusion Criteria:

1. Unequivocal positive common iliac or para-aortic lymph nodes at pretherapeutic imaging FDG-PET/CT
2. Negative or equivocal pelvic lymph nodes at pretherapeutic imaging FDG-PET/CT
3. Metastatic disease confirmed by FDG-PET/CT
4. Other histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma
5. Contraindication for cisplatin-based chemotherapy
6. Women who received any prior treatment for cervical cancer
7. Prior surgery for the cervical cancer, except for cone procedure and pelvic lymph node staging
8. Previous pelvic radiotherapy
9. History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease after 5 years, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ (any location) without evidence of disease.
10. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
11. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Where this trial is running

Pilsen and 33 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Cervical Carcinoma, Adenocarcinoma, Adenosquamous Carcinoma, Locally advanced cervical cancer, HPV 16+, Stage IIIC1, Radiation therapy, Cisplatin

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.