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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Toulouse

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Trial duration

17 Jul 2020 → ongoing

Decision date (initial)

2024-05-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

External identifiers

EU CT number

2024-513576-18-00

EudraCT number

2018-001415-75

ClinicalTrials.gov

NCT03534713

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 3

1. Assess and compare effect of induction chemotherapy with three cycles of Carboplatin and Paclitaxel followed by standard treatment (concurrent chemoradiotherapy) versus standard treatment alone, in patients with locally advanced cervical cancer with para-aortic lymph node involvement, with respect to the following: - Tumour response. - Progression-free survival. - Site of disease recurrence. - Health-related quality of life.
2. Assess local and para-aortic lymph node response after induction chemotherapy with three cycles of Carboplatin and Paclitaxel in patients with locally advanced cervical cancer with para-aortic lymph node involvement
3. Assess safety of induction chemotherapy with three cycles of Carboplatin and Paclitaxel followed by standard treatment (concurrent chemoradiotherapy) in patients with locally advanced cervical cancer with para-aortic lymph node involvement

Conditions and MedDRA coding

Cervical Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 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
2. Age ≥18 years
3. ECOG performance status of 0 to 2
4. FIGO stage IIIC2 or IVA WITH para-aortic lymph node involvement at the time of diagnosis
5. Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma
6. Normal renal function (creatinine clearance ≥60 mL/min)
7. Normal liver function (total bilirubin <1.5 times the upper limit of normal (ULN) and AST <3 ULN)
8. Normal haematological assessment (platelets >100×109/L and neutrophils >1.5×109/L)
9. Women of childbearing potential and not postmenopausal must have a negative blood serum or urine pregnancy test before starting the study treatment
10. Signed written informed consent
11. Affiliated to a social security insurance or equivalent

Exclusion criteria 7

1. Patients who have received prior chemotherapy or radiotherapy for their cervical cancer
2. Pregnant or breastfeeding women
3. History of invasive cancer (in the last five years) other than non-melanoma skin cancer
4. Acute, uncontrolled cardiovascular disease
5. Peripheral neuropathy of CTCAE grade 3-4
6. Known hypersensitivity to Paclitaxel, Cisplatin or other platinum-containing compounds
7. Patients under legal protection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 5

1. 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
2. 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
3. Site of disease recurrence (local, pelvic and/or para-aortic lymph nodes, distant)
4. Health-related quality of life, assessed using the EORTC QLQ-C30 questionnaire and the QLQ-CX24 module
5. Adverse events occurring from the first study treatment administration, assessed based on the NCI-CTCAE version 5.0

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Toulouse

Sponsor organisation

Centre Hospitalier Universitaire De Toulouse

Address

2 Rue Viguerie

City

Toulouse

Postcode

31300

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

MOTTON Stéphanie

Public contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

BOGDANOVITCH Laura

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications