Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
342
Countries
2
Sites
33
- Resected tumors of sinuses or salivary glands - Non-operable tumors of sinuses or salivary glands - Carcinomas of major salivary glands - Malignant tumors of sinuses
To Compare progression free survival (PFS) between the 2 treatment arms: RT only versus RT-CT as adjuvant therapy in surgical patients
Key facts
- Sponsor
- Groupe Oncologie Radiotherapie Tete Cou
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jan 2017 → ongoing
- Decision date (initial)
- 2024-08-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513972-16-00
- EudraCT number
- 2016-001816-39
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
To Compare progression free survival (PFS) between the 2 treatment arms: RT only versus RT-CT as adjuvant therapy in surgical patients
Secondary objectives 5
- Compare the 2 treatment arms in operated patients in terms of: • Overall survival (OS) • Quality of life (QoL) • Time to locoregional progression • Time to distant progression • Severe acute toxicity (grade ≥ 3 occurring during treatment and within the following 6 months) • Severe late toxicity (grade ≥ 3 occurring from 6 months after the end of radiotherapy treatment)
- Evaluate major and minor prognostic factors (T, R1 margins, high-grade histological subtypes according to REFCOR, N+ with/without capsular rupture, perineural sheathing, vascular emboli)
- Compare the oncological efficacy (PFS, OS, Time to progression) between the 2 arms in non-operated patients and study whether the effect of adding chemotherapy is similar in operated and non-operated patients.
- Evaluate the specific toxicity of proton therapy associated with cisplatin
- Analyze the oncological results by type of histology (Adenoid Cystic Carcinoma, intestinal type carcinoma, high-grade salivary gland tumors)
Conditions and MedDRA coding
- Resected tumors of sinuses or salivary glands - Non-operable tumors of sinuses or salivary glands - Carcinomas of major salivary glands - Malignant tumors of sinuses
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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
- 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.
- Age ≥ 18 years
- Performance index according to the World Health Organization (WHO) criteria from 0 to 2
- 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
- Estimated life expectancy greater than or equal to 6 months
Exclusion criteria 4
- History of radiotherapy in the ENT region and/or neoadjuvant chemotherapy for the pathology concerned
- Synchronous metastases
- Contraindications to the administration of cisplatin or carboplatin
- Other cancer, except in situ cervical cancer, skin carcinoma (except melanoma) or cancer controlled for more than 5 years
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival
Secondary endpoints 7
- Overall survival
- Quality of life
- Time to locoregional progression
- Time to distance progression
- Rate of acute toxicity grade ≥ 3
- Rate of late toxicities of grade ≥ 3
- Prognostic criteria
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cisplatin 1 mg/ml Concentrate for Solution for Infusion
PRD1951618 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 43 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- S00850
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- Cyprus
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Groupe Oncologie Radiotherapie Tete Cou
- Sponsor organisation
- Groupe Oncologie Radiotherapie Tete Cou
- Address
- 4 B Rue Emile Zola
- City
- Tours
- Postcode
- 37000
- Country
- France
Scientific contact point
- Organisation
- Groupe Oncologie Radiotherapie Tete Cou
- Contact name
- Dr François Regis FERRAND
Public contact point
- Organisation
- Groupe Oncologie Radiotherapie Tete Cou
- Contact name
- Adeline PECHERY
Locations
2 EU/EEA countries · 33 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 2 | 1 |
| France | Ongoing, recruitment ended | 340 | 32 |
| Rest of world | — | 0 | — |
Investigational sites
CHU De Charleroi Hopital Andre Vesale
Oncology-Radiotherapy, Rue De Gozee 706, 6110, Montigny-Le-Tilleul
Institut Curie
Medical oncology, 26 Rue D Ulm, 75005, Paris
Centre Marie Curie
Oncology-Radiotherapy, 159 boulevard du Maréchal Juin, 26000, Valence
Groupement De Cooperation Sanitaire Risssa Recherche & Innovation Sante Sarcelles
Oncology-Radiotherapy, 6 Avenue Charles Peguy, 95200, Sarcelles
Centre Hospitalier Universitaire De Nantes
Head and neck surgery, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Regional Universitaire De Tours
Radiotherapy, 2 Boulevard Tonnelle, 37000, Tours
Centre Antoine Lacassagne
Radiotherapy, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Clinique Victor Hugo
Oncology-Radiotherapy, 18 Rue Victor Hugo, Cs 81514, Le Mans Cedex 2
Centre Hospitalier Lyon Sud
Radiotherapy, 165 Chemin du Grand Revoyet, 69495 Pierre Bénite, Pierre Bénite
Centre Hospitalier De Niort
Oncology-Radiotherapy, 40 Avenue Charles De Gaulle, 79000, Niort
Centre Hospitalier Universitaire Amiens Picardie
Oncology-Radiotherapy, 1 Place Victor Pauchet, 80080, Amiens
Institut De Cancerologie De L Ouest
Medical oncology, 15 Rue Andre Boquel, 49100, Angers
Assistance Publique Hopitaux De Paris
Radiotherapy, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Regional De Marseille
Radiotherapy, 264 Rue Saint Pierre, 13005, Marseille
Besancon University Hospital Center
Oncology-Radiotherapy, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Francois Baclesse
Oncology-Radiotherapy, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut De Cancerologie De Lorraine
Radiotherapy, 6 Avenue De Bourgogne, 54500, Vandouvre Les Nancy
Centre De Lutte Contre Le Cancer Eugene Marquis
Radiotherapy, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Hopital Tenon
Oncology-Radiotherapy, 4 Rue De La Chine, 75970, Paris Cedex 20
Centre Hospitalier Universitaire D Orleans
Oncology-Radiotherapy, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier Universitaire Reims
Oncology-Radiotherapy, Rue Du General Koenig, 51092, Reims Cedex
Institut De Cancerologie De L Ouest
Medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Oscar Lambret
Radiotherapy, 3 Rue Frederic Combemale, 59000, Lille
Centre Hospitalier Universitaire De Bordeaux
Medical oncology, 1 Rue Jean Burguet, 33000, Bordeaux
Centr Georges Francois Leclerc
Radiotherapy, 1 Rue Professeur Marion, 21000, Dijon
Institut Gustave Roussy
Medical oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
University Hospital Of Clermont-Ferrand
Head and neck surgery, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut De Cancerologie Strasbourg Europe
Medical oncology, 17 Rue Albert Calmette, 67200, Strasbourg
Assistance Publique Hopitaux De Paris
Oncology-Radiotherapy, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Hopital Nord Franche Comte
Radiotherapy, 100 Route De Moval, 90400, Trevenans
Centre Hospitalier Intercommunal Creteil
Oncology-Radiotherapy, 40 Avenue De Verdun, 94000, Creteil
Centre Hospitalier Valence
Head and neck surgery, 179 Boulevard Marechal Juin, 26000, Valence
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2022-12-21 | 2022-12-27 | 2024-10-08 | ||
| France | 2017-01-30 | 2017-01-30 | 2025-03-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513972-16-00_public | 8.1 |
| Recruitment arrangements (for publication) | Document pas applicable | 1 |
| Recruitment arrangements (for publication) | Document pas applicable | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_ ancilliary_public | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_DE_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_FR_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_NL_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_public | 6.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatine_BE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatine_FR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DE 2024-513972-16-00_public | 8 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR 2024-513972-16-00_public | 8 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL 2024-513972-16-00_public | 8 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-10 | France | Acceptable 2024-08-27
|
2024-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-20 | France | Acceptable 2025-06-17
|
2025-06-18 |