Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)

July 3, 2023 updated by: The Netherlands Cancer Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif, France, 94800
        • Gustave Roussy Cancer Institute
  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Netherlands Cancer Institute
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Maastricht, Netherlands, NL-6229 ET
        • Maastro clinic
      • Rotterdam, Netherlands, 3075 EA
        • Erasmus Medical Centre
      • Utrecht, Netherlands, NL-3508GA
        • University Medical Centre Utrecht
  • Spain
      • Barcelona, Spain, 08035
        • University Hospital Vall d'Hebron
  • Sweden
      • Stockholm, Sweden, 17177
        • Karolinska Institute
  • United Kingdom
      • Manchester, United Kingdom, M20 5BX
        • Christie Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
locoregional recurrence-free survival
Time Frame: 2 years
2 years
number of patients with grade 3 toxicity or more
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2 years
2 years
progression free survival
Time Frame: 2 years
2 years
Quality of Life assessment
Time Frame: 2 years
2 years
swallowing preservation
Time Frame: 1 year
Tube feeding dependency at one year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimated)

January 5, 2012

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11ART

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on cisplatinum

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe