Clinical trial · Interventional
Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study cancelled
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Helical intensity-modulated radiotherapy (IMRT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Radiotherapy treatment
- interventionNames
- Other: Helical intensity-modulated radiotherapy (IMRT)
Primary outcomes (1)
- 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)
- timeFrame
- 7 weeks for each patient
Secondary outcomes (3)
- measure
- Rate of patients with DSC > 0.85 for other organs at risk (oral cavity, medullar canal, mandible,brain stem, larynx)
- timeFrame
- 7 weeks for each patient
- measure
- Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old 2. Patient with histologically proven locally advanced head and neck cancer (Oropharynx, hypopharynx, larynx, nasopharynx, oral cavity, sinuses, nasal cavities, ethmoid sinus, cavum, salivary glands) 3. Cancer with nodal involvement (at least T3 or involved node \>2 cm) 4. Eastern Cooperative Oncology Group performance status 0 or 1 5. No previous curative treatment for head and neck cancer (surgery and/or radiotherapy and/or chemotherapy) 6. Indication of exclusive radiotherapy (+/- chemotherapy) validated in multidisciplinary meeting 7. Patient affiliated to the french social security system. 8. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure. Exclusion Criteria: 1. Patient with metastatic cancer 2. Eastern Cooperative Oncology Group performance status ≥ 2 (due to comorbidities) 3. Patient with recurrent disease 4. Patient who required urgent surgical treatment 5. Contraindications to radiotherapy 6. History of cancer within 5 years 7. Patient already included in another therapeutic trial 8. Pregnant or breastfeeding women 9. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures 10. Patient protected by law
References
Publications (1)
- BACKGROUNDEsteyrie 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. PMID 30949592