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Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy (GIRAFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03953352
Recruitment Status : Withdrawn (Study cancelled)
First Posted : May 16, 2019
Last Update Posted : September 1, 2020
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Radiotherapy treatment 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03953352

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Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
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Responsible Party: Institut Claudius Regaud Identifier: NCT03953352    
Other Study ID Numbers: 19VADS01
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Adaptive radiotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site