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

Centre Hospitalier Universitaire De Toulouse13 sites in 1 country310 target enrollmentMay 28, 2024

DrugsCarboplatin Accord Healthcare 10 mg/ml, solution à diluer pour de perfusion PACLITAXEL KABI 6 mg/ml, solution à diluer pour perfusion.

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Centre Hospitalier Universitaire De Toulouse
Enrollment: 310
Locations: 13
Primary Endpoint: Overall survival defined as the time from the date of randomization to the date of death from any cause
Status: Suspended
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

euclinicaltrials.eu

Start Date

May 28, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Centre Hospitalier Universitaire De Toulouse

Responsible Party

Principal Investigator

MOTTON Stéphanie

Scientific

Centre Hospitalier Universitaire De Toulouse

Eligibility Criteria

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)

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

Outcomes

Primary Outcomes

Overall survival defined as the time from the date of randomization to the date of death from any cause

Secondary Outcomes

Tumour response at the end of standard treatment (concurrent chemoradiotherapy), based on investigator assessments according to both RECIST 1.1 and PERCIST 1.0 criteria
Progression-free survival, defined as the time from the date of randomization to the date of progression (based on investigator assessments according to RECIST 1.1 criteria) or the date of death from any cause, whichever occurs first
Site of disease recurrence (local, pelvic and/or para-aortic lymph nodes, distant)
Health-related quality of life, assessed using the EORTC QLQ-C30 questionnaire and the QLQ-CX24 module
Adverse events occurring from the first study treatment administration, assessed based on the NCI-CTCAE version 5.0