PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

Launched by INSTITUT CLAUDIUS REGAUD · Oct 12, 2022

Keywords

ClinConnect Summary

The PARa-aOrtic LymphAdenectomy study is a clinical trial that aims to see if a specific surgical procedure called para-aortic lymphadenectomy, followed by personalized chemotherapy and radiation treatment, can help women with stage IIIC1 cervical cancer live longer without their disease returning. In this trial, patients will be randomly assigned to one of two groups: one will receive standard treatment, while the other will undergo the additional surgery before their treatment. This study is being conducted in multiple countries, including France, with a total of 510 participants expected.

To participate, women must be at least 18 years old and have recently been diagnosed with specific types of cervical cancer. They should also be eligible for certain treatments and have a good overall health status. Participants will be monitored for five years to track their health and the effectiveness of the treatments. Additionally, the study will explore various aspects of the disease and treatment to understand how the body responds and the potential costs and benefits of the new approach. If you or someone you know fits the criteria and is interested in this research, it could be an opportunity to contribute to advancing cervical cancer treatments.

Gender

FEMALE

Eligibility 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).