Head and Neck Squamous Cell CarcinomaPhase 3ELAN-RTNCT01864850
Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC
A Phase 3 study testing Standard RT and Hypofractionated RT in people with Head and Neck Squamous Cell Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou at 2 sites in 2 countries.
Trial summary
Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Standard RT and Hypofractionated RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Oct 2013to 5 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 70 or over
- SIOG group 2 (vulnerable)
- Life expectancy > 12 weeks
- PS < 2
- Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary).
- First line treatment
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- At least one measurable lesion (RECIST)
- Stage II to IV
- Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized
- Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area
- Consent form signed
Who cannot join
- Primary squamous cell carcinoma of sinus, the skin or of the salivary glands
- Stage I cancer
- Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy
- Prior radiotherapy of head and neck area
- Concurrent chemotherapy or immunotherapy or hormonotherapy
- Induction chemotherapy
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- Concomitant infection requiring IV antibiotics
- cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted)
- conditions that could lead to bad compliance
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma
Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Standard RT, Hypofractionated RT
- Keywords
- HNSCC, Elderly, Geriatry
- 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.
Standard RTRadiation
70 Gy / 7 weeks / 2 Gy per fraction
Hypofractionated RTRadiation
55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy
| Study group | Role | What they receive |
|---|---|---|
| Standard RT | Active comparator | 70 Gy / 7 weeks / 2 Gy per fraction Receives: Radiation: Standard RT |
| Hypofractionated RT | Experimental | 55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy Receives: Radiation: Hypofractionated RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control
Patient alive with locoregional control at 6 months after the end of radiotherapy
Measured: 6 months
Secondary outcomes (8)
Acute toxicity
Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade
Measured: 3 months
Late toxicity
Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade
Measured: 18 months
Autonomy
Autonomy according to ADL scale
Measured: 18 months
Health related quality of life
Quality of life according to EORTC QLQ-C30 and QLQ-HN35
Measured: 18 months
Overall survival
Overall survival
Measured: 18 months
Locoregional progression
Locoregional progression
Measured: 18 months
metastasis progression
metastasis progression
Measured: 18 months
Progression free survival
Progression free survival
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study start18 Oct 2013
- Primary completionJun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Radiotherapy
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864850
- Sponsor's protocol ID
- GORTEC ELAN-RT
- Acronym
- ELAN-RT
- Status last verified
- Sep 2023
- First submitted
- 21 May 2013
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data Monitoring Committee will meet every year either by a physical meeting or by conference call. Data on the recruitment, toxicity and autonomy are submitted every year.
Publications
Ortholan C, Auperin A, Tao Y, Renard S, Pointreau Y, Lafond C, Bera G, Boisselier P, Benezery K, Racadot S, Huguet F, Bollet M, Braccini AL, Khoury C, Jacquot S, Villa J, Martin L, Di Rito A, Wiazzane N, Goineau A, Dupin C, Cartier L, Ruffier A, Cheurfa N, Schwob D, Mertens C, Le Caer H, Bourhis J, Guigay J, Sun XS; ELAN Group including Gustave Roussy, Unicancer GERICO and the H&N groups, and the GORTEC. Hypofractionated split-course versus standard radiotherapy in frail older patients with head and neck squamous-cell carcinoma (ELAN-RT trial): a non-inferiority, multicentre, open-label, randomised controlled trial. Lancet Healthy Longev. 2026 Jan;7(1):100812. doi: 10.1016/j.lanhl.2025.100812. Epub 2026 Feb 16.
PubMed 41713468
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01864850
- Acronym / sponsor ID
- ELAN-RT / GORTEC ELAN-RT
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- HNSCC, Elderly, Geriatry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 30 May 2013 (estimated)
- 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.
Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Standard RT | Active comparator | Radiation: Standard RT70 Gy / 7 weeks / 2 Gy per fraction |
| Hypofractionated RT | Experimental | Radiation: Hypofractionated RT55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Patients aged 70 or over
- SIOG group 2 (vulnerable)
- Life expectancy > 12 weeks
- PS < 2
- Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary).
Key exclusion criteria (9 listed)
- Primary squamous cell carcinoma of sinus, the skin or of the salivary glands
- Stage I cancer
- Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy
- Prior radiotherapy of head and neck area
- Concurrent chemotherapy or immunotherapy or hormonotherapy
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 |
|---|---|---|
| Standard RT70 Gy / 7 weeks / 2 Gy per fraction | Radiation | Standard RT |
| Hypofractionated RT55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy | Radiation | Hypofractionated RT |
Primary outcome
Locoregional control
Time frame: 6 months
Patient alive with locoregional control at 6 months after the end of radiotherapy
8 secondary outcomes
Acute toxicity
Time frame: 3 months
Late toxicity
Time frame: 18 months
Autonomy
Time frame: 18 months
Health related quality of life
Time frame: 18 months
Overall survival
Time frame: 18 months
Locoregional progression
Time frame: 18 months
metastasis progression
Time frame: 18 months
Progression free survival
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 41713468Ortholan C, Auperin A, Tao Y, Renard S, Pointreau Y, Lafond C, Bera G, Boisselier P, Benezery K, Racadot S, Huguet F, Bollet M, Braccini AL, Khoury C, Jacquot S, Villa J, Martin L, Di Rito A, Wiazzane N, Goineau A, Dupin C, Cartier L, Ruffier A, Cheurfa N, Schwob D, Mertens C, Le Caer H, Bourhis J, Guigay J, Sun XS; ELAN Group including Gustave Roussy, Unicancer GERICO and the H&N groups, and the GORTEC. Hypofractionated split-course versus standard radiotherapy in frail older patients with head and neck squamous-cell carcinoma (ELAN-RT trial): a non-inferiority, multicentre, open-label, randomised controlled trial. Lancet Healthy Longev. 2026 Jan;7(1):100812. doi: 10.1016/j.lanhl.2025.100812. Epub 2026 Feb 16.
- GORTECLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data Monitoring Committee will meet every year either by a physical meeting or by conference call. Data on the recruitment, toxicity and autonomy are submitted every year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard RT and Hypofractionated RT in people with Head and Neck Squamous Cell Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou at 2 sites in 2 countries.
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 11 inclusion and 9 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: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Monaco. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864850, which also lists 1 linked publication.
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 22 Sep 2023.