Cervical cancer with positive para-aortic lymph nodes MedDRA version: 21.1 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: CARBOPLATINE
Pharmaceutical Form: Solution for infusion
Trade Name: PACLITAXEL
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: CISPLATINE
Pharmaceutical Form: Conc
Sponsors
CHU de TOULOUSE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient with cervical cancer WITH positive para-aortic lymph nodes determined by either a positive 18F-FDG PET-CT, or a negative PET-CT, by histological examination of para-aortic lymph nodes. - Age =18 years - WHO performance status: stages 0 to 2 - FIGO stage IB1 to IVA at the time of diagnosis WITH positive para-aortic lymph nodes - Adenocarcinoma or squamous cell carcinoma or adenosquamous or mixed carcinoma - Normal renal function (creatinine clearance 75x109/l and neutrophils >1X109/l) - Women of childbearing and non-menopausal age must have a negative blood serum or urine pregnancy test before starting the study treatment - Having given his/her written consent - Affiliated to a social security scheme or equivalent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 310 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients who have first received 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 - Patient under legal protection - Acute, uncontrolled cardiovascular disease - Peripheral neuropathy of grade 2 or higher - Known hypersensitivity to Paclitaxel, Cisplatin or products containing platinum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether the addition of induction chemotherapy with three cycles of Carboplatin and Paclitaxel plus standard concomitant radiotherapy and chemotherapy improves overall survival compared to standard therapy in patients with cervical cancer with positive para-aortic lymph nodes;Secondary Objective: - compare progression-free survival between the two treatment arms - compare tumour responses between the two treatment arms - compare the quality of life between the two treatment arms - compare types of relapse between the two treatment arms - evaluate the tolerance - to evaluate the local and aortic lymph node response after induction chemotherapy in the experimental arm only;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Defined as the time from the date of randomisation to the date of death, regardless of the cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - tumour response according to the RECIST v1.1 and PERCIST criteria - progression-free survival, time from the date of randomisation to the date of progression (according to the RECIST v1.1 and/or PERCIST criteria) or the date of death, regardless of the cause, depending on which event occurs first - location of the relapse (local, pelvic and/or aortic lymph node, distant) - quality of life (QLQ-C30 and QLQ-CX24) - adverse events that occur during the trial after the informed consent forms have been signed, as defined in NCI-CTCAE version 5.0;Timepoint(s) of evaluation of this end point: - At the end of study treatment - Before induction chemotherapy, before and at the end of concomitant radiochemotherapy, at the first follow-up visit and once a year for the first three years of follow-up | — |
Countries
France
Contacts
Public ContactLaura BOGDANOVITCH
CHU de TOULOUSE
Outcome results
None listed