NCT01504815: ARTFORCE

Adaptive Radiation Treatment for Head and Neck Cancer

Completed Phase 3 Last updated 29 January 2025

What this trial tests

Phase 3 trial testing cisplatinum in Head and Neck Cancer in 268 participants. Completed in 24 December 2024.

Timeline

7 September 2012

Primary endpoint
1 December 2021

24 December 2024

Quick facts

Lead sponsor	The Netherlands Cancer Institute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	268
Start date	7 September 2012
Primary completion	1 December 2021
Estimated completion	24 December 2024
Sites	9 locations across France, Netherlands, Sweden, United Kingdom, Spain

Drugs / interventions tested

• cisplatinum — full drug profile →
• Conventional radiotherapy
• Adaptive radiotherapy

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

The Netherlands Cancer Institute

Who can join

Adults 18 to 70, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase III trial aims to:

Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.

The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.

To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adaptive Radiation Therapy (ART) Strategies and Technical Considerations: A State of the ART Review From NRG Oncology.
   Glide-Hurst CK, Lee P, Yock AD, Olsen JR, et al · · 2021 · cited 210× · PMID 33470210 · DOI 10.1016/j.ijrobp.2020.10.021
2. Monoclonal antibody-based molecular imaging strategies and theranostic opportunities.
   Dammes N, Peer D. · · 2020 · cited 93× · PMID 31903161 · DOI 10.7150/thno.37443
3. Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcomE (ARTFORCE); a randomized controlled phase II trial for individualized treatment of head and neck cancer.
   Heukelom J, Hamming O, Bartelink H, Hoebers F, et al · · 2013 · cited 86× · PMID 23433435 · DOI 10.1186/1471-2407-13-84
4. Magnetic resonance linear accelerator technology and adaptive radiation therapy: An overview for clinicians.
   Hall WA, Paulson E, Li XA, Erickson B, et al · · 2022 · cited 76× · PMID 34792808 · DOI 10.3322/caac.21707
5. Radiotherapy toxicities: mechanisms, management, and future directions.
   Verginadis II, Citrin DE, Ky B, Feigenberg SJ, et al · · 2025 · cited 60× · PMID 39827884 · DOI 10.1016/s0140-6736(24)02319-5
6. Theranostic applications of antibodies in oncology.
   Fleuren ED, Versleijen-Jonkers YM, Heskamp S, van Herpen CM, et al · · 2014 · cited 44× · PMID 24725480 · DOI 10.1016/j.molonc.2014.03.010
7. Quantitative assessment of Zirconium-89 labeled cetuximab using PET/CT imaging in patients with advanced head and neck cancer: a theragnostic approach.
   Even AJ, Hamming-Vrieze O, van Elmpt W, Winnepenninckx VJ, et al · · 2017 · cited 43× · PMID 27965472 · DOI 10.18632/oncotarget.13910
8. Hypoxia PET Imaging with [18F]-HX4-A Promising Next-Generation Tracer.
   Sanduleanu S, Wiel AMAV, Lieverse RIY, Marcus D, et al · · 2020 · cited 35× · PMID 32455922 · DOI 10.3390/cancers12051322