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New treatment option for Cervical Carcinoma
Official title PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer
ClinicalTrials.gov ID: NCT05581121
What this study is testing
- What it's testing
- This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET/CT only followed by chemoradiation. The planned sample size is 510; including 200 patients in France.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age ≥ 18 years at time of study entry
- Newly diagnosed histologically proven cervical squamous carcinoma, adenocarcinoma, or adenosquamous tumor
- FIGO stage IIIC1 (FIGO 2018) cervical cancer with FDG-PET/CT showing FDG-positive pelvic nodes and FDG-negative PALN including equivocal lymph nodes...
- Patients with TNM T stage I-IIIB.
- FIGO stage IIIC1 cervical cancer by positive pelvic sentinel lymph node from surgical staging (either intraoperative assessment (frozen section) or...
You likely can't join if
- Unequivocal positive common iliac or para-aortic lymph nodes at pretherapeutic imaging FDG-PET/CT
- Negative or equivocal pelvic lymph nodes at pretherapeutic imaging FDG-PET/CT
- Metastatic disease confirmed by FDG-PET/CT
- Other histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma
- Contraindication for cisplatin-based chemotherapy
- Women who received any prior treatment for cervical cancer
See the full eligibility criteria
- Age ≥ 18 years at time of study entry
- Newly diagnosed histologically proven cervical squamous carcinoma, adenocarcinoma, or adenosquamous tumor
- 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...
- Patients with TNM T stage I-IIIB.
- 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...
- Patient eligible for pelvic radiotherapy and cisplatin-based chemotherapy with a curative intent as confirmed by a multidisciplinary board
- ECOG performance status \< 2 i.e. 0 or 1
- Life expectancy more than 12 months
- Pretherapeutic imaging FDG-PET/CT images should be available for central review
- Prior validation of the surgeon's participation in the study by the Quality Assurance Comity
- 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...
- 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
- 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...
- Signed informed consent
- Patient affiliated to a Social Health Insurance in France (French patients only).
- Unequivocal positive common iliac or para-aortic lymph nodes at pretherapeutic imaging FDG-PET/CT
- Negative or equivocal pelvic lymph nodes at pretherapeutic imaging FDG-PET/CT
- Metastatic disease confirmed by FDG-PET/CT
- Other histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma
- Contraindication for cisplatin-based chemotherapy
- Women who received any prior treatment for cervical cancer
- Prior surgery for the cervical cancer, except for cone procedure and pelvic lymph node staging
- Previous pelvic radiotherapy
- 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...
- 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
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
The study team makes the final eligibility decision.
Where it's taking place
- Ostrava, Czechia
- Pilsen, Czechia
- Prague, Czechia
- Angers, France
- Bordeaux, France
- Brest, France
- Caen, France
- Créteil, France
- Dijon, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nîmes, France
- Paris, France
- Pierre-Bénite, France
- Reims, France
- Rouen, France
- Saint-Cloud, France
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ostrava, Czechia; Pilsen, Czechia; Prague, Czechia; Angers, France; Bordeaux, France; Brest, France and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.