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Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)

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ClinicalTrials.gov Identifier: NCT01504815
Recruitment Status : Recruiting
First Posted : January 5, 2012
Last Update Posted : September 28, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: cisplatinum Radiation: Conventional radiotherapy Radiation: Adaptive radiotherapy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2012
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. locoregional recurrence-free survival [ Time Frame: 2 years ]
  2. number of patients with grade 3 toxicity or more [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Quality of Life assessment [ Time Frame: 2 years ]
  2. swallowing preservation [ Time Frame: 1 year ]
    Tube feeding dependency at one year

  3. progression free survival [ Time Frame: 2 years ]
  4. overall survival [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504815


Contacts
Contact: Olga Hamming-Vrieze, MD +31205122135 o.vrieze@nki.nl
Contact: Harry Bartelink, MD, PhD +31205129111 h.bartelink@nki.nl

Locations
France
Gustave Roussy Cancer Institute 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         
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Roel Steenbakkers, MD, PhD       r.steenbakkers@umcg.nl   
Principal Investigator: Roel Steenbakkers, MD, PhD         
Maastro Clinic Recruiting
Maastricht, Netherlands, NL-6229 ET
Contact: Frank Hoebers, MD    +31 88 4455521    frank.hoebers@maastro.nl   
Principal Investigator: Frank Hoebers, MD         
Erasmus Medical Centre Recruiting
Rotterdam, Netherlands, 3075 EA
Contact: Lisa Tans, MD, PhD       l.tans@erasmusmc.nl   
Principal Investigator: Lisa Tans, MD, PhD         
University Medical Centre Utrecht 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: Berta Garrido    +34 93 2746000 ext 4695    bgarrido@vhebron.net   
Principal Investigator: Jordi Giralt, MD         
Sweden
Karolinska Institute 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 Recruiting
Manchester, United Kingdom, M20 5BX
Contact: Nick Slevin, MD    +44 161 9187939    nick.slevin@christie.nhs.uk   
Principal Investigator: Nick Slevin, MD         
Sponsors and Collaborators
The Netherlands Cancer Institute
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
More Information

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
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

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

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