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Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)

This study is currently recruiting participants.
Verified May 2013 by The Netherlands Cancer Institute
Sponsor:
Collaborators:
Karolinska Institutet
Maastricht Radiation Oncology
Institut Catala de Salut
Christie Hospital NHS Foundation Trust
Institut Gustave Roussy
European Union
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01504815
First received: December 15, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This Phase II 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.

Test the predictive value of Zr89-Cetuximab uptake in vivo for treatment specific outcome. For all patients the Zr89-Cetuximab uptake in the primary tumor will be determined before the start of treatment.

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


Condition Intervention Phase
Head and Neck Cancer
 Drug: cisplatinum
Radiation: radiotherapy
Drug: Cetuximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Study With Cisplatinum or Cetuximab and Standard or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • locoregional recurrence-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • correlation of the median Zr89-cetuximab uptake with locoregional recurrence-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • swallowing preservation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Tube feeding dependency at one year

  • progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 268
Study Start Date: March 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cisplatinum + standard RT
weekly cisplatinum, RT 70 Gy in 35 fractions
 Drug: cisplatinum
i.v. 40 mg/m2, weekly, 6 weeks
Radiation: radiotherapy
conventional radiotherapy, 70Gy in 35 daily fractions in 6 weeks
Experimental: Cisplatinum + adaptive high dose RT
weekly cisplatinum, adaptive high dose RT 64-84 Gy in 35 fractions
 Drug: cisplatinum
i.v. 40mg/m2, weekly, 6 weeks
Radiation: radiotherapy
adaptive high dose radiotherapy 64-84Gy, 35 daily fractions in 6 weeks
Active Comparator: Cetuximab + standard RT
weekly Cetuximab, conventional RT 70 Gy in 35 fractions
 Drug: Cetuximab
i.v. 250 mg/m2, weekly, 6 weeks
Radiation: radiotherapy
conventional radiotherapy, 70Gy in 35 daily fractions in 6 weeks
Experimental: Cetuximab + adaptive high dose RT
weekly Cetuximab, adaptive high dose RT 64-84 Gy in 35 fractions
 Drug: Cetuximab
i.v. 250 mg/m2, weekly for 6 weeks
Radiation: radiotherapy
adaptive high dose radiotherapy, 64-84Gy in 35 daily fractions in 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504815

Contacts
Contact: Olga Hamming-Vrieze, MD +31205122135 o.vrieze@nki.nl

Locations
Netherlands
Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Olga Hamming-Vrieze, MD     +31205122135     o.vrieze@nki.nl    
Principal Investigator: Olga Hamming-Vrieze, MD            
Maastro Clinic Recruiting
Maastricht, Netherlands, NL-6229 ET
Contact: Frank Hoebers, MD     +31 88 4455521     frank.hoebers@maastro.nl    
Principal Investigator: Frank Hoebers, MD            
Sponsors and Collaborators
The Netherlands Cancer Institute
Karolinska Institutet
Maastricht Radiation Oncology
Institut Catala de Salut
Christie Hospital NHS Foundation Trust
Institut Gustave Roussy
European Union
Investigators
Principal Investigator: Olga Hamming-Vrieze, MD The Netherlands Cancer Institute
  More Information

No publications provided by The Netherlands Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT01504815     History of Changes
Other Study ID Numbers: M11ART
Study First Received: December 15, 2011
Last Updated: May 7, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
advanced head and neck cancer
adaptive radiotherapy
cisplatinum
Zr89-labeled Cetuximab

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Cisplatin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013