Optimized early care for head and neck squamous cell carcinoma
Official title: Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck
Run by Centre Henri Becquerel · NCT04528420 · Data updated 2026-11-12
This program tries extra nutrition and supportive care to help adults with localized head and neck squamous cell carcinoma complete post‑operative cisplatin chemoradiation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 138 (estimated) |
| Sponsor | Centre Henri Becquerel Academic / other |
| Locations | 7 sites (Amiens and 6 other locations) |
| Status | Recruiting |
| Started | November 26, 2020 |
| Main results expected | December 1, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT04528420 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with localized head and neck squamous cell carcinoma who are planned for curative postoperative cisplatin‑based chemoradiation and have WHO performance status 0–1 are ideal candidates.
✕Probably not a fit
Patients with prior head and neck radiotherapy, recent or progressive other cancers, contraindications to cisplatin, pregnant or breastfeeding women, or those unable to follow the protocol are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
After surgery, many patients struggle to start and complete cisplatin‑based postoperative chemoradiation because of recent weight loss, delayed recovery of swallowing, and treatment‑related mucositis. This interventional protocol provides optimized early management including structured nutritional support and enhanced supportive care during postoperative concomitant radiochemotherapy to improve tolerance and treatment completion. Eligible adults (18–75 years) with localized head and neck squamous cell carcinoma and WHO performance status <2 are enrolled, excluding those with prior head‑and‑neck radiotherapy, contraindications to cisplatin, or recent other cancers. The trial is run at regional French centers and tracks completion of three cisplatin cycles along with functional and nutritional outcomes.
Why it matters
Potential benefit: If successful, the approach could increase the number of patients who complete the full three cycles of postoperative cisplatin chemoradiation with fewer interruptions and better nutritional status.
How similar studies have gone: Previous trials report moderate completion rates for postoperative cisplatin chemoradiation (about 50–70%), and while nutritional and supportive interventions have been used, this particular early optimized management approach is relatively novel in predominantly non‑HPV populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * History of other neoplastic disease less than 2 years old or progressive, * History of radiotherapy for head and neck cancer, * 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
Where it's running
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CHU Amiens
Amiens, France Recruiting -
CH Beauvais
Beauvais, France Recruiting -
Centre Guillaume le Conquérant
Le Havre, France Recruiting -
CHRU Lille
Lille, France Recruiting -
Centre Henri Becquerel
Rouen, France Recruiting -
CH Saint-Quentin
Saint-Quentin, France Recruiting
Show 1 more location
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Clinique du Parc
Caen, France Not yet recruiting
Study contacts
- Study coordinator: Florian Clatot, MD,PhD
- Email: florian.clatot@chb.unicancer.fr
- Phone: +33232082231
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.