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

Head and Neck Cancer Clinical Trial

— GIRAFE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03953352
• Other study ID #: 19VADS01
• Status: Withdrawn
• Phase: N/A
• Start date: August 2019
• Est. completion date: January 2021

Study information

• Verified date: August 2020
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85)		7 weeks for each patient
Secondary	Rate of patients with DSC > 0.85 for other organs at risk (oral cavity, medullar canal, mandible,brain stem, larynx)		7 weeks for each patient
Secondary	Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume)		7 weeks for each patient
Secondary	Time saving defined by the difference between standard recontouring time (manuel recontouring) and experimental recontouring time (Precise ART™ or Precise RTX™)		7 weeks for each patient