Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)

• ClinicalTrials.gov Identifier: NCT01504815
• Recruitment Status: Active, not recruiting
• First Posted: January 5, 2012
• Last Update Posted: July 6, 2023
• Sponsor: The Netherlands Cancer Institute
• Collaborators: Karolinska Institutet; Maastricht Radiation Oncology; Institut Catala de Salut; The Christie NHS Foundation Trust; Gustave Roussy, Cancer Campus, Grand Paris; UMC Utrecht; European Union
• Information provided by (Responsible Party): The Netherlands Cancer Institute

Tracking Information

• First Submitted Date: December 15, 2011
• First Posted Date: January 5, 2012
• Last Update Posted Date: July 6, 2023
• Study Start Date: March 2012
• Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 21, 2014)

• locoregional recurrence-free survival [ Time Frame: 2 years ]
• number of patients with grade 3 toxicity or more [ Time Frame: 2 years ]

Original Primary Outcome Measures (submitted: January 3, 2012)

• locoregional recurrence-free survival [ Time Frame: 2 years ]
• correlation of the median Zr89-cetuximab uptake with locoregional recurrence-free survival [ Time Frame: 2 years ]
  This outcome measure correlates the pretreatment ZR89-Cetuximab uptake on imaging with locoregional recurrence.
• number of patients with grade 3 toxicity or more [ Time Frame: 2 years ]

Current Secondary Outcome Measures (submitted: January 3, 2012)

• Quality of Life assessment [ Time Frame: 2 years ]
• swallowing preservation [ Time Frame: 1 year ]
  Tube feeding dependency at one year
• progression free survival [ Time Frame: 2 years ]
• overall survival [ Time Frame: 2 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adaptive Radiation Treatment for Head and Neck Cancer
• Official Title: Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Head and Neck Cancer

Intervention

• Drug: cisplatinum
  i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
• Radiation: Conventional radiotherapy
  conventional radiotherapy, 70Gy in 7 weeks
• Radiation: Adaptive radiotherapy
  adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks

Study Arms

• Active Comparator: Cisplatinum + conventional RT
  Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks
  Interventions:

  • Drug: cisplatinum
  • Radiation: Conventional radiotherapy
• Experimental: Cisplatinum + adaptive high dose RT
  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
  Interventions:

  • Drug: cisplatinum
  • Radiation: Adaptive radiotherapy

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 3, 2012): 268
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2025
• Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands, France, Spain, Sweden, United Kingdom

Administrative Information

• NCT Number: NCT01504815
• Other Study ID Numbers: M11ART
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: The Netherlands Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: The Netherlands Cancer Institute
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Olga Hamming-Vrieze, MD; The Netherlands Cancer Institute

• PRS Account: The Netherlands Cancer Institute
• Verification Date: July 2023