Head and Neck CancerGIRAFENCT03953352
Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy
A study testing Helical intensity-modulated radiotherapy (IMRT) in people with Head and Neck Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily MVCT (MegaVoltage Computerized Tomography)) using the Precise ART™ software in patients with head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Helical intensity-modulated radiotherapy (IMRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2019to Jan 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Patient with histologically proven locally advanced head and neck cancer (Oropharynx, hypopharynx, larynx, nasopharynx, oral cavity, sinuses, nasal cavities, ethmoid sinus, cavum, salivary glands)
- Cancer with nodal involvement (at least T3 or involved node >2 cm)
- Eastern Cooperative Oncology Group performance status 0 or 1
- No previous curative treatment for head and neck cancer (surgery and/or radiotherapy and/or chemotherapy)
- Indication of exclusive radiotherapy (+/- chemotherapy) validated in multidisciplinary meeting
- Patient affiliated to the french social security system.
- Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure.
Who cannot join
- Patient with metastatic cancer
- Eastern Cooperative Oncology Group performance status ≥ 2 (due to comorbidities)
- Patient with recurrent disease
- Patient who required urgent surgical treatment
- Contraindications to radiotherapy
- History of cancer within 5 years
Show all 10Show fewer
- Patient already included in another therapeutic trial
- Pregnant or breastfeeding women
- Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
- Patient protected by law
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Toulouse
About this study
This trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily MVCT (MegaVoltage Computerized Tomography)) using the Precise ART™ software in patients with head and neck cancer.
Patients will receive helical intensity-modulated radiotherapy (IMRT) according to the standard recommendations (35 fractions during 7 weeks). Radiotherapy will include daily repositioning MVCT.
Read more
For the study, patients will undergo 4 intermediate re-planning CT-scan (without injection of intravenous contrast agent) at week 3, week 4, week 5 and week 6 of treatment.
3 recontouring modalities will be evaluated for the study:
- Manuel recontouring (standard method)
- Precise ART™ deformed contours
- Precise RTX™ deformed contours
The total duration of the study for each patient will be 7 weeks.
- Conditions
- Head and Neck Cancer
- Being tested
- Helical intensity-modulated radiotherapy (IMRT)
- Keywords
- Adaptive radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helical intensity-modulated radiotherapy (IMRT)Other
Helical intensity-modulated radiotherapy (35 fractions, 5 fractions per week) will be administered during 7 weeks: 2 Gy per fraction on tumor and 1.6 Gy per fraction on bilateral lymph node areas.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy treatment | Other | Not described Receives: Other: Helical intensity-modulated radiotherapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85)
Measured: 7 weeks for each patient
Secondary outcomes (3)
Rate of patients with DSC > 0.85 for other organs at risk (oral cavity, medullar canal, mandible,brain stem, larynx)
Measured: 7 weeks for each patient
Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume)
Measured: 7 weeks for each patient
Time saving defined by the difference between standard recontouring time (manuel recontouring) and experimental recontouring time (Precise ART™ or Precise RTX™)
Measured: 7 weeks for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study startAug 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: Study cancelled
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 CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953352
- Sponsor's protocol ID
- 19VADS01
- Acronym
- GIRAFE
- Status last verified
- Apr 2026
- First submitted
- 14 May 2019
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esteyrie V, Gleyzolle B, Lusque A, Graff P, Modesto A, Rives M, Lapeyre M, Desrousseaux J, Graulieres E, Hangard G, Arnaud FX, Ferrand R, Delord JP, Poublanc M, Mounier M, Filleron T, Laprie A. The GIRAFE phase II trial on MVCT-based "volumes of the day" and "dose of the day" addresses when and how to implement adaptive radiotherapy for locally advanced head and neck cancer. Clin Transl Radiat Oncol. 2019 Mar 9;16:34-39. doi: 10.1016/j.ctro.2019.02.006. eCollection 2019 May.
PubMed 30949592
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy
- ClinicalTrials.gov ID
- NCT03953352
- Acronym / sponsor ID
- GIRAFE / 19VADS01
- Conditions
- Head and Neck Cancer
- Keywords
- Adaptive radiotherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 16 May 2019 (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.
This trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily MVCT (MegaVoltage Computerized Tomography)) using the Precise ART™ software in patients with head and neck cancer.
Patients will receive helical intensity-modulated radiotherapy (IMRT) according to the standard recommendations (35 fractions during 7 weeks). Radiotherapy will include daily repositioning MVCT.
For the study, patients will undergo 4 intermediate re-planning CT-scan (without injection of intravenous contrast agent) at week 3, week 4, week 5 and week 6 of treatment.
3 recontouring modalities will be evaluated for the study:
- Manuel recontouring (standard method)
- Precise ART™ deformed contours
- Precise RTX™ deformed contours
The total duration of the study for each patient will be 7 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy treatment | Other | Other: Helical intensity-modulated radiotherapy (IMRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old
- Patient with histologically proven locally advanced head and neck cancer (Oropharynx, hypopharynx, larynx, nasopharynx, oral cavity, sinuses, nasal cavities, ethmoid sinus, cavum, salivary glands)
- Cancer with nodal involvement (at least T3 or involved node >2 cm)
- Eastern Cooperative Oncology Group performance status 0 or 1
- No previous curative treatment for head and neck cancer (surgery and/or radiotherapy and/or chemotherapy)
Key exclusion criteria (10 listed)
- Patient with metastatic cancer
- Eastern Cooperative Oncology Group performance status ≥ 2 (due to comorbidities)
- Patient with recurrent disease
- Patient who required urgent surgical treatment
- Contraindications to radiotherapy
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 |
|---|---|---|
| Helical intensity-modulated radiotherapy (IMRT)Helical intensity-modulated radiotherapy (35 fractions, 5 fractions per week) will be administered during 7 weeks: 2 Gy per fraction on tumor and 1.6 Gy per fraction on bilateral lymph node areas. | Other | Radiotherapy treatment |
Primary outcome
Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85)
Time frame: 7 weeks for each patient
3 secondary outcomes
Rate of patients with DSC > 0.85 for other organs at risk (oral cavity, medullar canal, mandible,brain stem, larynx)
Time frame: 7 weeks for each patient
Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume)
Time frame: 7 weeks for each patient
Time saving defined by the difference between standard recontouring time (manuel recontouring) and experimental recontouring time (Precise ART™ or Precise RTX™)
Time frame: 7 weeks for each patient
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 30949592Esteyrie V, Gleyzolle B, Lusque A, Graff P, Modesto A, Rives M, Lapeyre M, Desrousseaux J, Graulieres E, Hangard G, Arnaud FX, Ferrand R, Delord JP, Poublanc M, Mounier M, Filleron T, Laprie A. The GIRAFE phase II trial on MVCT-based "volumes of the day" and "dose of the day" addresses when and how to implement adaptive radiotherapy for locally advanced head and neck cancer. Clin Transl Radiat Oncol. 2019 Mar 9;16:34-39. doi: 10.1016/j.ctro.2019.02.006. eCollection 2019 May.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helical intensity-modulated radiotherapy (IMRT) in people with Head and Neck Cancer, run by Institut Claudius Regaud at 1 site 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 8 inclusion and 10 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: withdrawn, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85) (time frame: 7 weeks for each patient). 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 NCT03953352, 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 15 Apr 2026.