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

Institut Claudius Regaud

Status: Withdrawn

Conditions: Head and Neck Cancer

Treatments: Other: Helical intensity-modulated radiotherapy (IMRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03953352

19VADS01

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Radiotherapy treatment

Other group

Treatment:

Other: Helical intensity-modulated radiotherapy (IMRT)