Adaptive Radiation Treatment for Head and Neck Cancer

Conditions

Head and Neck Cancer

Keywords

advanced head and neck cancer, adaptive radiotherapy, cisplatinum

Brief summary

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.

de Leeuw ALMP, Hoebers FJP, Giralt J, Tao Y, Terhaard CHJ, Lee LW, Friesland S, Steenbakkers RJHM, Tans L, Kayembe MT, van Kranen SR, Bartelink H, Rasch CRN, Sonke JJ, Hamming-Vrieze O.

2025-07-10

10.1016/j.radonc.2025.111044

Protocol compliance in a multicentric phase III trial investigating scheduled adaptive radiotherapy and dose painting in head and neck cancer.

de Leeuw ALMP, Giralt J, Tao Y, Benavente S, Nguyen TF, Hoebers FJP, Hoeben A, Terhaard CHJ, Lee LW, Friesland S, Steenbakkers RJHM, Tans L, van Kranen SR, van de Kamer JB, Bartelink H, Rasch CRN, Sonke JJ, Hamming-Vrieze O.

2024-11-09

10.1016/j.radonc.2024.110612

Adaptive FDG-PET/CT guided dose escalation in head and neck squamous cell carcinoma: Late toxicity and oncologic outcomes (The ADMIRE study).

Al-Mamgani A, Kessels R, Gouw ZAR, Navran A, Mohan V, van de Kamer JB, Sonke JJ, Vogel WV.

2023-09-176 citations

10.1016/j.ctro.2023.100676

[<sup>18</sup>F]-HX4 PET/CT hypoxia in patients with squamous cell carcinoma of the head and neck treated with chemoradiotherapy: Prognostic results from two prospective trials.

Sanduleanu S, Hamming-Vrieze O, Wesseling FWR, Even AJG, Hoebers FJ, Hoeben A, Vogel WV, Tesselaar MET, Parvin D, Bartelink H, Lambin P.

2020-04-1817 citations

10.1016/j.ctro.2020.04.004

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, Giralt J, Herlestam T, Verheij M, van den Brekel M, Vogel W, Slevin N, Deutsch E, Sonke JJ, Lambin P, Rasch C.

2013-02-2286 citations

10.1186/1471-2407-13-84

Interventions

DRUGcisplatinum

i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy

RADIATIONConventional radiotherapy

conventional radiotherapy, 70Gy in 7 weeks

RADIATIONAdaptive radiotherapy

adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

* biopsy-confirmed squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx * stage III/IV, T3-4, Nx M0 * \< 70 yrs * glomerular filtration rate (GFR) \>60 * WHO 0-1 * no previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix * adequate bone marrow function, adequate hepatic function,informed consent * \>18 years

Exclusion criteria

* expected failure from follow-up * previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix * expected inability to complete either one of the treatment arms * pregnancy or lactation * patients (m/f) with reproductive potential not implementing adequate contraceptive measures * prior surgery, radiotherapy or chemotherapy for this tumor * contraindications or serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or are likely to interfere with the study assessments * known active symptomatic fungal, bacterial and/or viral infections including HIV * concomitant (or with 4 weeks before randomisation) administration of any other experimental drug * concurrent treatment with any other anti-cancer therapy * prior treatment with one or more of the active compounds

Design outcomes

Primary

Measure	Time frame
locoregional recurrence-free survival	2 years
number of patients with grade 3 toxicity or more	2 years

Secondary

Measure	Time frame	Description
Quality of Life assessment	2 years	—
swallowing preservation	1 year	Tube feeding dependency at one year
progression free survival	2 years	—
overall survival	2 years	—

Countries

France, Netherlands, Spain, Sweden, United Kingdom

Outcome results

None listed