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

Primary Purpose

Head and Neck Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Helical intensity-modulated radiotherapy (IMRT)
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head and Neck Cancer focused on measuring Adaptive radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiotherapy treatment

Arm Description

Outcomes

Primary Outcome Measures

Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85)

Secondary Outcome Measures

Rate of patients with DSC > 0.85 for other organs at risk (oral cavity, medullar canal, mandible,brain stem, larynx)
Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume)
Time saving defined by the difference between standard recontouring time (manuel recontouring) and experimental recontouring time (Precise ART™ or Precise RTX™)

Full Information

First Posted
May 14, 2019
Last Updated
August 31, 2020
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT03953352
Brief Title
Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy
Acronym
GIRAFE
Official Title
Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study cancelled
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Adaptive radiotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy treatment
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Helical intensity-modulated radiotherapy (IMRT)
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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