NCT03953352

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

May 14, 2019

Last Update Submit

April 10, 2026

Conditions

Head and Neck Cancer

Keywords

Adaptive radiotherapy

Outcome Measures

Primary Outcomes (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)

    7 weeks for each patient

Secondary Outcomes (3)

  • 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

  • Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume)

    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™)

    7 weeks for each patient

Study Arms (1)

Radiotherapy treatment

OTHER
Other: Helical intensity-modulated radiotherapy (IMRT)

Interventions

Helical intensity-modulated radiotherapy (IMRT)OTHER

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.

Radiotherapy treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toulouse, France

Location

Related Publications (1)

  • Esteyrie V, Gleyzolle B, Lusque A, Graff P, Modesto A, Rives M, Lapeyre M, Desrousseaux J, Graulieres E, Hangard G, Arnaud FX, Ferrand R, Delord JP, Poublanc M, Mounier M, Filleron T, Laprie A. The GIRAFE phase II trial on MVCT-based "volumes of the day" and "dose of the day" addresses when and how to implement adaptive radiotherapy for locally advanced head and neck cancer. Clin Transl Radiat Oncol. 2019 Mar 9;16:34-39. doi: 10.1016/j.ctro.2019.02.006. eCollection 2019 May.

    PMID: 30949592BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 16, 2019

Study Start

August 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

FR(1)