Optimized early care for head and neck squamous cell carcinoma
Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Centre Henri Becquerel Academic / other |
| Locations | 7 sites (Amiens and 6 other locations) |
| Trial ID | NCT04528420 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amiens and 6 other locations
- CHU Amiens — Amiens, France (Recruiting)
- CH Beauvais — Beauvais, France (Recruiting)
- Clinique du Parc — Caen, France (Not_yet_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)
Study contacts
- Study coordinator: Florian Clatot, MD,PhD
- Email: florian.clatot@chb.unicancer.fr
- Phone: +33232082231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.