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NCT04528420Recruiting

Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer

Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck

Source: ClinicalTrials.gov · Last updated 2 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
138 (estimated)
First submitted
29 Jul 2020
Start date
26 Nov 2020
Primary completion date
1 Dec 2027
Lead sponsor
Centre Henri Becquerel
NCT number
NCT04528420

What you commit to

  • Study type: Interventional
  • Planned participants: 138
  • From 26 Nov 2020 to the primary completion date, 1 Dec 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of radiotherapy for head and neck cancer,

Age

  • History of other neoplastic disease less than 2 years old or progressive,

Other

  • Contraindications to cisplatin,
  • Pregnant or breastfeeding woman,
  • Protected major (under guardianship or curatorship),
  • Patient participating in a therapeutic study
  • Patient unable to understand the study for any reason or to comply with the constraints of the trial

Who the study is looking for

  • Male or female, over 18 and under 75 years of age,
  • Worl Health Organisation score \< 2,
  • Treatment for a localized squamous cell carcinoma of the head and neck for which a curative treatment by concomitant post-operative radiochemotherapy based on cisplatin is retained,
  • Having signed the informed consent,
  • Affiliate or beneficiary of a social protection scheme.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Amiens
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AmiensFranceRecruiting
CH Beauvais
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BeauvaisFranceRecruiting
Clinique du Parc
Coordinator of this site? Confirm its status
CaenFranceNot yet recruiting
Centre Guillaume le Conquérant
Coordinator of this site? Confirm its status
Le HavreFranceRecruiting
CHRU Lille
Coordinator of this site? Confirm its status
LilleFranceRecruiting
Centre Henri Becquerel
Coordinator of this site? Confirm its status
RouenFranceRecruiting
CH Saint Quentin
Coordinator of this site? Confirm its status
Saint-QuentinFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.