Squamous Cell Carcinoma of Head and NeckOPTINECKNCT04528420
Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer
A study testing optimised management in people with Squamous Cell Carcinoma of Head and Neck, run by Centre Henri Becquerel at 7 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- optimised management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 7 sitesFrance
- Study dates
- 26 Nov 2020to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
CHU Amiens
Amiens
Alexandre COUTTE, MD
- Recruiting
CH Beauvais
Beauvais
Hanifa AMMARGUELLAT, MD
- Not yet recruiting
Clinique du Parc
Caen
Emmanuel Sevin, MD
- Recruiting
Centre Guillaume le Conquérant
Le Havre
Laurent Martin, MD
- Recruiting
CHRU Lille
Lille
François MOUAWAD, MD
- Recruiting
Centre Henri Becquerel
Rouen
Florian Clatot, Md,PHD, +33232082231, florian.clatot@chb.unicancer.fr
Sebastien Thureau, MD,PhD, +033276673030, sebastien.thureau@chb.unicancer.fr
- Recruiting
CH Saint-Quentin
Saint-Quentin
Farid BELKHIR, MD
About this study
Official title: Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck
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
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- optimised management
- Keywords
- radiochemotherapy, nutrition, support care, early management
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optimised managementOther
At the inclusion , the patient will benefit from an early consultation with a nutritionist, a pain doctor and a social worker.
During the preparation phase for radiotherapy the patient will benefit from weekly consultations with a pain nurse and a dietician.
During the radiotherapy the patient will be weighed daily and have an assessment of their nutritional needs and a weekly consultation with a pain nurse and dietician and then twice a month until three months post-radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Optimised arm | Experimental | Patients will be taken care of early and optimally way. Receives: Other: optimised management |
| Standard arm | No intervention | Patients will be monitored as in standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing of the impact of early multimodal management on weight loss measured between the inclusion consultation and 3 months post-treatment.
Proportion of patients with at least 5% reduction in weight at 3 months post-treatment compared to the inclusion consultation
Measured: 3 months post treatment
Secondary outcomes (5)
Assessing the impact of multimodal management on overall survival and progression-free survival at 18 months post-treatment
Overall and progression-free survival rate at 18 months post-treatment
Measured: 18 months post treatment
Assessing the impact of multimodal management on the percentage of patients receiving the full treatment as planned
Percentage of patients who received all the treatment as planned
Measured: 1 month
Assessing the impact of multimodal management on the percentage of patients receiving level 3 analgesics during radio-chemotherapy and up to 3 months post-treatment
Number of patients who level 3 analgesics has been prescribed
Measured: 3 months post treatment
Assessing the impact of multimodal management on average weight loss
Average of difference of weight at the end of the study and weight at the inclusion
Measured: 18 months post treatment
Medico-economic analysis of multimodal management using the cost-utility method
Cost-utility ratio in each arm
Measured: 18 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start26 Nov 2020
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Thureau, MD,PhD, Study director, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528420
- Sponsor's protocol ID
- CHB19.01
- Acronym
- OPTINECK
- Status last verified
- Dec 2025
- First submitted
- 29 Jul 2020
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT04528420
- Acronym / sponsor ID
- OPTINECK / CHB19.01
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- radiochemotherapy, nutrition, support care, early management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimised arm | Experimental | Other: optimised managementPatients will be taken care of early and optimally way. |
| Standard arm | No intervention | –Patients will be monitored as in standard practice |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optimised managementAt the inclusion , the patient will benefit from an early consultation with a nutritionist, a pain doctor and a social worker. During the preparation phase for radiotherapy the patient will benefit from weekly consultations with a pain nurse and a dietician. During the radiotherapy the patient will be weighed daily and have an assessment of their nutritional needs and a weekly consultation with a pain nurse and dietician and then twice a month until three months post-radiotherapy. | Other | Optimised arm |
Primary outcome
Assessing of the impact of early multimodal management on weight loss measured between the inclusion consultation and 3 months post-treatment.
Time frame: 3 months post treatment
Proportion of patients with at least 5% reduction in weight at 3 months post-treatment compared to the inclusion consultation
5 secondary outcomes
Assessing the impact of multimodal management on overall survival and progression-free survival at 18 months post-treatment
Time frame: 18 months post treatment
Assessing the impact of multimodal management on the percentage of patients receiving the full treatment as planned
Time frame: 1 month
Assessing the impact of multimodal management on the percentage of patients receiving level 3 analgesics during radio-chemotherapy and up to 3 months post-treatment
Time frame: 3 months post treatment
Assessing the impact of multimodal management on average weight loss
Time frame: 18 months post treatment
Medico-economic analysis of multimodal management using the cost-utility method
Time frame: 18 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sébastien Thureau, MD,PhD study director
Centre Henri Becquerel
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optimised management in people with Squamous Cell Carcinoma of Head and Neck, run by Centre Henri Becquerel at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Clatot, MD,PhD (+33232082231, florian.clatot@chb.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing of the impact of early multimodal management on weight loss measured between the inclusion consultation and 3 months post-treatment. (time frame: 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.