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

Phase 1

Conditions: Cervical Cancer
MedDRA version: 21.1Level: LLTClassification code: 10008229Term: Cervical cancer Class: 10029104
MedDRA version: 21.1Level: LLTClassification code: 10008236Term: Cervical cancer stage IV Class: 10029104
MedDRA version: 21.1Level: LLTClassification code: 10008235Term: Cervical cancer stage III Class: 10029104
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Therapeutic area: Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Registration Number: CTIS2024-513576-18-00

Lead Sponsor: Centre Hospitalier Universitaire De Toulouse

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 310

Inclusion 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

Exclusion Criteria

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