Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy (GIRAFE)
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|ClinicalTrials.gov Identifier: NCT03953352|
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Other: Helical intensity-modulated radiotherapy (IMRT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Other: 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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953352
|Contact: LAPRIE Anne||05 31 15 54 email@example.com|
|Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)||Not yet recruiting|
|Contact: LAPRIE Anne 05 31 15 54 43 firstname.lastname@example.org|