Clinical trial • Phase III • Oncology

CISPLATIN for Malignant tumors of paranasal sinuses | Salivary gland carcinoma

Phase III trial of CISPLATIN for Malignant tumors of paranasal sinuses | Salivary gland carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Malignant tumors of paranasal sinuses | Salivary gland carcinoma
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-07-2024
First CTIS Authorization Date
28-08-2024

Trial design

Randomised, rt only versus rt + cisplatin (cisplatin 1 mg/ml concentrate for solution for infusion; dosing unit mg/m2; max daily dose 100 mg/m2; max total dose 300 mg/m2) — radiotherapy alone comparator arm and radiotherapy with concomitant cisplatin chemotherapy experimental arm.-controlled Phase III trial across 33 sites in France, Belgium.

Randomised
Yes
Comparator
RT only versus RT + Cisplatin (Cisplatin 1 mg/ml Concentrate for Solution for Infusion; dosing unit mg/m2; max daily dose 100 mg/m2; max total dose 300 mg/m2) — radiotherapy alone comparator arm and radiotherapy with concomitant cisplatin chemotherapy experimental arm.
Target Sample Size
342
Trial Duration For Participant
2149

Eligibility

Recruits 342 No vulnerable populations selected; participants must be ≥ 18 years. Informed consent forms are provided for adults (subject information and informed consent form documents available for adults)..

Vulnerable Population
No vulnerable populations selected; participants must be ≥ 18 years. Informed consent forms are provided for adults (subject information and informed consent form documents available for adults).

Inclusion criteria

  • {"criterion_text":"- Resected tumors of the sinuses or salivary glands: T3-4 N0 or T1-4 N1-3 or T1-2 N0 with invaded edges or positive margins (< 5 mm) or Unresectable or inoperable tumors of the sinuses or salivary glands"}
  • {"criterion_text":"- Carcinomas of the main salivary glands (parotid, submandibular or sublingual glands) and accessories or Malignant tumors of the sinuses with any histological type except melanomas, lymphomas, mesenchymal tumors (sarcoma type), squamous cell carcinomas and nasopharyngeal carcinomas of type 1, 2, 3."}
  • {"criterion_text":"- Age ≥ 18 years"}
  • {"criterion_text":"- Performance index according to the World Health Organization (WHO) criteria from 0 to 2"}
  • {"criterion_text":"- For patients ≥ 70 years, the G8 questionnaire score must be > 14 with no falls noted in the previous 12 months or presenting a geriatric assessment compatible with the administration of chemotherapy"}
  • {"criterion_text":"- Estimated life expectancy greater than or equal to 6 months"}

Exclusion criteria

  • {"criterion_text":"- History of radiotherapy in the ENT region and/or neoadjuvant chemotherapy for the pathology concerned"}
  • {"criterion_text":"- Synchronous metastases"}
  • {"criterion_text":"- Contraindications to the administration of cisplatin or carboplatin"}
  • {"criterion_text":"- Other cancer, except in situ cervical cancer, skin carcinoma (except melanoma) or cancer controlled for more than 5 years"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival","definition_or_measurement_approach":"To Compare progression free survival (PFS) between the 2 treatment arms: RT only versus RT-CT as adjuvant therapy in surgical patients"}

Secondary endpoints

  • {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomisation to death from any cause"}
  • {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Assessment of Quality of Life (QoL) (specific instruments not listed in JSON)"}
  • {"endpoint_text":"- Time to locoregional progression","definition_or_measurement_approach":"Time until locoregional progression"}
  • {"endpoint_text":"- Time to distance progression","definition_or_measurement_approach":"Time until distant progression"}
  • {"endpoint_text":"- Rate of acute toxicity grade ≥ 3","definition_or_measurement_approach":"Severe acute toxicity defined as grade ≥ 3 occurring during treatment and within the following 6 months"}
  • {"endpoint_text":"- Rate of late toxicities of grade ≥ 3","definition_or_measurement_approach":"Severe late toxicity defined as grade ≥ 3 occurring from 6 months after the end of radiotherapy treatment"}
  • {"endpoint_text":"- Prognostic criteria","definition_or_measurement_approach":"Evaluation of major and minor prognostic factors (T, R1 margins, high-grade histological subtypes according to REFCOR, N+ with/without capsular rupture, perineural sheathing, vascular emboli)"}

Recruitment

Planned Sample Size
342
Recruitment Window Months
70
Consent Approach
Informed consent is provided by the adult participant (Age ≥ 18). Subject information and informed consent form documents for adults are present (documents in French, German, Dutch and a general adults public version). No assent procedures for minors are provided because trial excludes participants <18 years.

Geography

Total Number Of Sites
33
Total Number Of Participants
342

France

Earliest CTIS Part Ii Submission Date
23-07-2024
Latest Decision Or Authorization Date
20-06-2025
Processing Time Days
332
Number Of Sites
32
Number Of Participants
340

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Radiotherapy
Contact Person Name
Stéphanie WONG HEE KAM
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Head and neck surgery
Contact Person Name
Olivier MALARD
Contact Person Email
olivier.malard@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Oncology-Radiotherapy
Contact Person Name
Olivier Munier
Contact Person Email
olivier.munier@chr-orleans.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Radiotherapy
Contact Person Name
Sophie OLDRINNI
Contact Person Email
s.renard@nancy.unicancer.fr
Site Name
Centre Hospitalier Valence
Department Name
Head and neck surgery
Contact Person Name
Guillaume BUIRET
Contact Person Email
gbuiret@ch-valence.fr
Site Name
Hopital Tenon
Department Name
Oncology-Radiotherapy
Contact Person Name
Florence HUGUET
Contact Person Email
florence.huguet@aphp.fr
Site Name
Institut Curie
Department Name
Medical oncology
Contact Person Name
Valentin CALUGRU
Contact Person Email
valentin.calugaru@curie.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Radiotherapy
Contact Person Name
Noémie VULQUIN
Contact Person Email
nvulquin@cgfl.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Oncology-Radiotherapy
Contact Person Name
Xavier CUENCA
Contact Person Email
xavier.cuenca@chicreteil.fr
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Medical oncology
Contact Person Name
Julie VANBOCKSTAEL
Site Name
Institut De Cancerologie De L Ouest (Saint-Herblain)
Department Name
Medical oncology
Contact Person Name
Frederic ROLLAND
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Radiotherapy
Contact Person Name
Jean CASTELLI
Contact Person Email
j.castelli@rennes.unicancer.fr
Site Name
Centre Marie Curie
Department Name
Oncology-Radiotherapy
Contact Person Name
Mathieu BOSSET
Contact Person Email
dr.bosset@cmc-valence.org
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Oncology-Radiotherapy
Contact Person Name
Alexandre COUTTE
Contact Person Email
coutte.alexandre@chu-amiens.fr
Site Name
Assistance Publique Hopitaux De Paris (Ambroise Pare)
Department Name
Oncology-Radiotherapy
Contact Person Name
Benjamin VERILLAUD
Contact Person Email
benjamin.verillaud@gmail.com
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Medical oncology
Contact Person Name
Sarah BETRIAN-LAGARDE
Contact Person Email
betrian.sarah@iuct-oncopole.fr
Site Name
Assistance Publique Hopitaux De Paris (Boulevard De L Hopital)
Department Name
Radiotherapy
Contact Person Name
Philippe Maingon
Contact Person Email
philippe.maingon@aphp.fr
Site Name
Besancon University Hospital Center
Department Name
Oncology-Radiotherapy
Contact Person Name
Salim BENHMIDA
Contact Person Email
sbenhmida@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medical oncology
Contact Person Name
Laurence DIGUE
Contact Person Email
laurence.digue@chu-bordeaux.fr
Site Name
Centre Oscar Lambret
Department Name
Radiotherapy
Contact Person Name
Isaure ROQUETTE
Contact Person Email
i-roquette@o-lambret.fr
Site Name
Centre Antoine Lacassagne
Department Name
Radiotherapy
Contact Person Name
Deborah Aloi
Contact Person Email
deborah.aloi@nice.unicancer.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Radiotherapy
Contact Person Name
Sophie CHAPET
Contact Person Email
s.chapet@chu-tours.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Oncology-Radiotherapy
Contact Person Name
Antonio DA SILVA RIBEIRO MOTA
Site Name
Institut Gustave Roussy
Department Name
Medical oncology
Contact Person Name
François-Regis FERRAND
Site Name
Centre Hospitalier Lyon Sud
Department Name
Radiotherapy
Contact Person Name
Ariane LAPIERRE
Contact Person Email
ariane.lapierre@chu-lyon.fr
Site Name
Centre Francois Baclesse
Department Name
Oncology-Radiotherapy
Contact Person Name
Juliette Thariat
Site Name
Groupement De Cooperation Sanitaire Risssa Recherche & Innovation Sante Sarcelles
Department Name
Oncology-Radiotherapy
Contact Person Name
Muriel BOTTI
Contact Person Email
murielbotti@gmail.com
Site Name
Centre Hospitalier De Niort
Department Name
Oncology-Radiotherapy
Contact Person Name
Riyadh Namoune
Contact Person Email
riyadh.namoune@ch-niort.fr
Site Name
Hopital Nord Franche Comte
Department Name
Radiotherapy
Contact Person Name
Xu-Shan SUN
Contact Person Email
xssun@chbm.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Head and neck surgery
Contact Person Name
Nicolas SAROUL
Contact Person Email
nsaroul@chu-clermontferrand.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Medical oncology
Contact Person Name
Mickaël BURGY
Contact Person Email
m.burgy@icans.eu
Site Name
Clinique Victor Hugo
Department Name
Oncology-Radiotherapy
Contact Person Name
Yoann POINTREAU
Contact Person Email
y.pointreau@ilcgroupe.fr

Belgium

Earliest CTIS Part Ii Submission Date
23-07-2024
Latest Decision Or Authorization Date
18-06-2025
Processing Time Days
330
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
CHU De Charleroi Hopital Andre Vesale
Department Name
Oncology-Radiotherapy
Contact Person Name
Nicolas MEERT
Contact Person Email
nicolas.meert@chu-charleroi.be

Sponsor

Primary sponsor

Full Name
Groupe Oncologie Radiotherapie Tete Cou
Organisation Type
Patient organisation/association
Country Of Registered Address
France

Third parties

  • {"country":"Cyprus","full_name":"ACCORD HEALTHCARE LIMITED","duties_or_roles":"Marketing authorisation holder / product supplier for Cisplatin","organisation_type":""}

Investigational products

Investigational Product Name
Cisplatin 1 mg/ml Concentrate for Solution for Infusion
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INFUSION
Route
Infusion
Authorisation Status
Authorised (marketing authorisation number S00850 in CY)
Maximum Dose
300 mg/m2
Combination Treatment
Yes

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