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Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)

Primary Purpose

Head and Neck Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cisplatinum
Conventional radiotherapy
Adaptive radiotherapy
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring advanced head and neck cancer, adaptive radiotherapy, cisplatinum

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gustave Roussy Cancer Institute
  • Netherlands Cancer Institute
  • Universitair Medisch Centrum Groningen
  • Maastro Clinic
  • Erasmus Medical Centre
  • University Medical Centre Utrecht
  • University Hospital Vall d'Hebron
  • Karolinska Institute
  • Christie Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cisplatinum + conventional RT

Cisplatinum + adaptive high dose RT

Arm Description

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

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

Outcomes

Primary Outcome Measures

locoregional recurrence-free survival
number of patients with grade 3 toxicity or more

Secondary Outcome Measures

Quality of Life assessment
swallowing preservation
Tube feeding dependency at one year
progression free survival
overall survival

Full Information

First Posted
December 15, 2011
Last Updated
July 3, 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
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1. Study Identification

Unique Protocol Identification Number
NCT01504815
Brief Title
Adaptive Radiation Treatment for Head and Neck Cancer
Acronym
ARTFORCE
Official Title
Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
advanced head and neck cancer, adaptive radiotherapy, cisplatinum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatinum + conventional RT
Arm Type
Active Comparator
Arm Description
Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks
Arm Title
Cisplatinum + adaptive high dose RT
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
cisplatinum
Intervention Description
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Conventional radiotherapy
Intervention Description
conventional radiotherapy, 70Gy in 7 weeks
Intervention Type
Radiation
Intervention Name(s)
Adaptive radiotherapy
Intervention Description
adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks
Primary Outcome Measure Information:
Title
locoregional recurrence-free survival
Time Frame
2 years
Title
number of patients with grade 3 toxicity or more
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of Life assessment
Time Frame
2 years
Title
swallowing preservation
Description
Tube feeding dependency at one year
Time Frame
1 year
Title
progression free survival
Time Frame
2 years
Title
overall survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Hamming-Vrieze, MD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gustave Roussy Cancer Institute
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastro Clinic
City
Maastricht
ZIP/Postal Code
NL-6229 ET
Country
Netherlands
Facility Name
Erasmus Medical Centre
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
University Medical Centre Utrecht
City
Utrecht
ZIP/Postal Code
NL-3508GA
Country
Netherlands
Facility Name
University Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Karolinska Institute
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 5BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23433435
Citation
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.
Results Reference
derived

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Adaptive Radiation Treatment for Head and Neck Cancer

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