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 : Recruiting
First Posted : May 16, 2019
Last Update Posted : August 9, 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 :||August 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953352
|Contact: LAPRIE Anne||05 31 15 54 firstname.lastname@example.org|
|Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)||Recruiting|
|Contact: LAPRIE Anne 05 31 15 54 43 email@example.com|