Adaptive Radiation Treatment for Head and Neck Cancer

NCT01504815 | Completed Phase 3

• 1 other identifier: M11ART
• Study Type: interventional
• Target: 268
• Locations: 5 countries
• Sites: 9

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.

Conditions

Head and Neck Cancer

Keywords

advanced head and neck cancer; adaptive radiotherapy; cisplatinum

Outcome Measures

Primary Outcomes (2)

• locoregional recurrence-free survival

  2 years

• number of patients with grade 3 toxicity or more

  2 years

Secondary Outcomes (4)

• Quality of Life assessment

  2 years

• swallowing preservation

  1 year

• progression free survival

  2 years

• overall survival

  2 years

Study Arms (2)

Cisplatinum + conventional RT

ACTIVE COMPARATOR

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

Drug: cisplatinum; Radiation: Conventional radiotherapy

Cisplatinum + adaptive high dose RT

EXPERIMENTAL

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

Drug: cisplatinum; Radiation: Adaptive radiotherapy

Interventions

cisplatinum DRUG

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

Cisplatinum + adaptive high dose RT; Cisplatinum + conventional RT

Conventional radiotherapy RADIATION

conventional radiotherapy, 70Gy in 7 weeks

Cisplatinum + conventional RT

Adaptive radiotherapy RADIATION

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

Cisplatinum + adaptive high dose RT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Karolinska Institutet: collaborator
• Maastricht Radiation Oncology: collaborator
• Institut Catala de Salut: collaborator
• The Christie NHS Foundation Trust: collaborator
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator
• UMC Utrecht: collaborator
• European Union: collaborator

Study Sites (9)

Gustave Roussy Cancer Institute

Villejuif, 94800, France

Location

Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Maastro Clinic

Maastricht, NL-6229 ET, Netherlands

Location

Erasmus Medical Centre

Rotterdam, 3075 EA, Netherlands

Location

University Medical Centre Utrecht

Utrecht, NL-3508GA, Netherlands

Location

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Karolinska Institute

Stockholm, 17177, Sweden

Location

Christie Hospital NHS Trust

Manchester, M20 5BX, United Kingdom

Location

Related Publications (1)

• 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. 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. BMC Cancer. 2013 Feb 22;13:84. doi: 10.1186/1471-2407-13-84.

  PMID: 23433435 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Olga Hamming-Vrieze, MD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: January 5, 2012
• Study Start: September 7, 2012
• Primary Completion: December 1, 2021
• Study Completion: December 24, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

GB (1); ES (1); NL (5); FR (1); SE (1)