- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03953352
Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy (GIRAFE)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Toulouse, Frankrike
- Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Radiotherapy treatment
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85)
Tidsramme: 7 weeks for each patient
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7 weeks for each patient
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rate of patients with DSC > 0.85 for other organs at risk (oral cavity, medullar canal, mandible,brain stem, larynx)
Tidsramme: 7 weeks for each patient
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7 weeks for each patient
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Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume)
Tidsramme: 7 weeks for each patient
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7 weeks for each patient
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Time saving defined by the difference between standard recontouring time (manuel recontouring) and experimental recontouring time (Precise ART™ or Precise RTX™)
Tidsramme: 7 weeks for each patient
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7 weeks for each patient
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 19VADS01
Legemiddel- og utstyrsinformasjon, studiedokumenter
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