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Induction chemotherapy followed by standard concurrent chemoradiotherapy in cervical cancer with para-aortic lymph node involvement: A phase III, multicenter, parallel-group randomized, controlled trial - ONCOCOL-01
EU CTIS ID: 2024-513576-18-00
What this study is testing
Evaluate whether induction chemotherapy with three cycles of Carboplatin and Paclitaxel followed by standard treatment (concurrent chemoradiotherapy) improves overall survival compared to standard treatment alone, in patients with locally advanced cervical cancer with para-aortic lymph node involvement.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient with cervical cancer WITH para-aortic lymph node involvement determined by either a positive 18F-FDG PET-CT (visual interpretation of metabolic activity of para-aortic lymph node, greater than the background noise), or by histological examination of para-aortic lymph nodes if negative 18F-FDG PET-CT
- Signed written informed consent
- Affiliated to a social security insurance or equivalent
- Age ≥18 years
- ECOG performance status of 0 to 2
- FIGO stage IIIC2 or IVA WITH para-aortic lymph node involvement at the time of diagnosis
You likely can't join if
- Patients who have received prior chemotherapy or radiotherapy for their cervical cancer
- Pregnant or breastfeeding women
- History of invasive cancer (in the last five years) other than non-melanoma skin cancer
- Acute, uncontrolled cardiovascular disease
- Peripheral neuropathy of CTCAE grade 3-4
- Known hypersensitivity to Paclitaxel, Cisplatin or other platinum-containing compounds
See the full eligibility criteria
- Patient with cervical cancer WITH para-aortic lymph node involvement determined by either a positive 18F-FDG PET-CT (visual interpretation of metabolic activity of para-aortic lymph node, greater than the background noise), or by histological examination of para-aortic lymph nodes if negative 18F-FDG PET-CT
- Signed written informed consent
- Affiliated to a social security insurance or equivalent
- Age ≥18 years
- ECOG performance status of 0 to 2
- FIGO stage IIIC2 or IVA WITH para-aortic lymph node involvement at the time of diagnosis
- Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma
- Normal renal function (creatinine clearance ≥60 mL/min)
- Normal liver function (total bilirubin <1.5 times the upper limit of normal (ULN) and AST <3 ULN)
- Normal haematological assessment (platelets >100×109/L and neutrophils >1.5×109/L)
- Women of childbearing potential and not postmenopausal must have a negative blood serum or urine pregnancy test before starting the study treatment
- Patients who have received prior chemotherapy or radiotherapy for their cervical cancer
- Pregnant or breastfeeding women
- History of invasive cancer (in the last five years) other than non-melanoma skin cancer
- Acute, uncontrolled cardiovascular disease
- Peripheral neuropathy of CTCAE grade 3-4
- Known hypersensitivity to Paclitaxel, Cisplatin or other platinum-containing compounds
- Patients under legal protection
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.