Actively Recruiting
Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer
Led by Centre Henri Becquerel · Updated on 2026-01-02
138
Participants Needed
7
Research Sites
392 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Post-operative concomitant radiochemotherapy is a treatment that is difficult to achieve for several reasons. First of all, and by definition, these patients have had recent surgery, most often accompanied by several weeks of hospitalization and weight loss. In addition, the functional recovery of feeding capacity is not always complete at the time of the start of irradiation. In addition, concomitant radiochemotherapy is responsible for very frequent radiomucitus which alters the feeding capacity of patients during treatment. In total, the rate of complete radiochemotherapy (3 cures of cisplatin administered) varies from 50 to 70% depending on the studies, which were carried out in selected populations within the framework of an experimental clinical trial and without distinguishing between positive and negative Human Papilloma tumours . In our experience, in a population with a very high preponderance of non-Human Papilloma-related tumours and not selected by participation in an experimental trial, complete radiochemotherapy is only possible in about 40% to 50% of cases.However, the amount of cisplatin actually administered is correlated with overall survival. Therefore, it is logical to assume that increasing the number of patients receiving full treatment may result in increased survival. While the need for nutritional care during radiotherapy is clearly established, its modality remains debated. Recently, a randomised study of 159 patients treated by radiotherapy (or radiochemotherapy) showed that the simple systematic prescription of oral food supplements (500 kcal/d) in addition to the usual dietary advice was associated with a lesser reduction in weight at the end of radiotherapy (main objective) but also with an improvement in the tolerance of the treatments. Overall, nutritional management during treatment varies greatly, ranging from simple dietary monitoring to prophylactic gastrostomy and the insertion of a nasogastric tube on demand during treatment. This heterogeneity of management found in the literature is also observed at the regional level. This project will also make it possible to propose a harmonized support strategy at the inter-regional level.
CONDITIONS
Official Title
Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, over 18 and under 75 years of age
- World Health Organisation score less than 2
- Treatment planned for localized squamous cell carcinoma of the head and neck with curative post-operative radiochemotherapy based on cisplatin
- Signed informed consent
- Affiliated with or beneficiary of a social protection scheme
You will not qualify if you...
- History of other cancer within the last 2 years or progressive cancer
- Previous radiotherapy for head and neck cancer
- Contraindications to cisplatin
- Pregnant or breastfeeding women
- Individuals under guardianship or curatorship
- Participation in another therapeutic study
- Inability to understand the study or comply with its requirements
AI-Screening
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Trial Site Locations
Total: 7 locations
1
CHU Amiens
Amiens, France
Actively Recruiting
2
CH Beauvais
Beauvais, France
Actively Recruiting
3
Clinique du Parc
Caen, France
Not Yet Recruiting
4
Centre Guillaume le Conquérant
Le Havre, France
Actively Recruiting
5
CHRU Lille
Lille, France
Actively Recruiting
6
Centre Henri Becquerel
Rouen, France
Actively Recruiting
7
CH Saint-Quentin
Saint-Quentin, France
Actively Recruiting
Research Team
F
Florian Clatot, MD,PhD
CONTACT
D
Doriane Richard, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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