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 3

Suspended

• Conditions: Cervical Cancer

• Registration Number: 2024-513576-18-00
• Lead Sponsor: Centre Hospitalier Universitaire De Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-05-28
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: Temporarily halted
• Sex: Female
• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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		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		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)		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		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		Adverse events occurring from the first study treatment administration, assessed based on the NCI-CTCAE version 5.0

Trial Locations

Locations (13)

Institut De Cancerologie De L Ouest; 🇫🇷 Saint-Herblain Cedex, France

University Hospital Of Clermont-Ferrand; 🇫🇷 Clermont Ferrand Cedex 1, France

Clinique Pasteur; 🇫🇷 Toulouse Cedex 3, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire De Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier Universitaire De Toulouse; 🇫🇷 Toulouse, France

Centre Hospitalier Universitaire De La Reunion; 🇫🇷 Saint-Denis, France

Hospices Civils De Lyon; 🇫🇷 Pierre Benite, France

Centre Hospitalier Regional Universitaire De Tours; 🇫🇷 Tours Cedex 9, France

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris, France

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Institut De Cancerologie De L Ouest

🇫🇷Saint-Herblain Cedex, France

Dominique BERTON

Site contact

0240679705

dominique.berton@ico.unicancer.fr