Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy
NCT ID: NCT03953352
Last Updated: 2020-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-08-31
2021-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Radiotherapy treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Toulouse, , France
Countries
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Other Identifiers
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19VADS01
Identifier Type: -
Identifier Source: org_study_id
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