Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The Netherlands Cancer Institute
Sponsor:
Collaborators:
Karolinska Institutet
Maastricht Radiation Oncology
Institut Catala de Salut
Christie Hospital NHS Foundation Trust
Gustave Roussy, Cancer Campus, Grand Paris
UMC Utrecht
European Union
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01504815
First received: December 15, 2011
Last updated: August 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatinum
Radiation: Conventional radiotherapy
Radiation: Adaptive radiotherapy
Phase 3

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 III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

Resource links provided by NLM:


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 ]
  • 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 + conventional RT
Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks
Drug: cisplatinum
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
Radiation: Conventional radiotherapy
conventional radiotherapy, 70Gy in 7 weeks
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
Drug: cisplatinum
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
Radiation: Adaptive radiotherapy
adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504815

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

Locations
France
Gustave Roussy Cancer Institute Not yet recruiting
Villejuif, France, 94800
Contact: Yungan Tao, MD    +33 1 42116532    yungan.tao@gustaveroussy.fr   
Principal Investigator: Yungan Tao, MD         
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         
University Medical Centre Not yet recruiting
Utrecht, Netherlands, NL-3508GA
Contact: Chris Terhaard, MD PhD    +31 88 7553137    c.h.j.terhaard@umcutrecht.nl   
Principal Investigator: Chris Terhaard, MD PhD         
Spain
University Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Jordi Giralt, MD       jgiralt@vhebron.net   
Contact: Oriol Nualart Mundo    +34 93 2746000 ext 4695    onualart@vhebron.net   
Principal Investigator: Jordi Giralt, MD         
Sweden
Karolinska Institute Not yet recruiting
Stockholm, Sweden, 17177
Contact: Teresa Herlestam, MD    +46 8 51770000    maria.herlestam-calero-moreno@karolinska.se   
Principal Investigator: Teresa Herlestam, MD         
United Kingdom
Christie Hospital NHS Trust Not yet recruiting
Manchester, United Kingdom, M20 5BX
Contact: Nick Slevin, MD    +44 161 9187939    nick.slevin@christie.nhs.uk   
Contact: Claudia Grimaldo    +44 161 4463045    claudia.grimaldo@manchester.ac.uk   
Principal Investigator: Nick Slevin, MD         
Sponsors and Collaborators
The Netherlands Cancer Institute
Karolinska Institutet
Maastricht Radiation Oncology
Institut Catala de Salut
Christie Hospital NHS Foundation Trust
Gustave Roussy, Cancer Campus, Grand Paris
UMC Utrecht
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: August 21, 2014
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

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

ClinicalTrials.gov processed this record on September 14, 2014