Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)

Netherlands Cancer Institute (NKI)

Status and phase: Completed; Phase 3

Conditions: Head and Neck Cancer

Treatments: Radiation: Adaptive radiotherapy; Drug: cisplatinum; Radiation: Conventional radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01504815

M11ART

Details and patient eligibility

About

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.

Enrollment: 268 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

Cisplatinum + conventional RT

Active Comparator group

Description:

Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks

Treatment:

Radiation: Conventional radiotherapy

Drug: cisplatinum

Cisplatinum + adaptive high dose RT

Experimental group

Description:

Cisplatinum, 100 mg/m2 on days 1, 22 and 43 with adaptive high dose RT to 84 Gy max on 50% uptake GTV in 7 weeks

Treatment:

Radiation: Adaptive radiotherapy

Drug: cisplatinum