Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04528420

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here