Adaptive Radiation Treatment for Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— ARTFORCE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01504815
• Other study ID #: M11ART
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2012
• Est. completion date: September 2025

Study information

• Verified date: July 2023
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 268
• Est. completion date: September 2025
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cisplatinum
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy

Radiation:
• Conventional radiotherapy
conventional radiotherapy, 70Gy in 7 weeks
• Adaptive radiotherapy
adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks

Locations

Country	Name	City	State
France	Gustave Roussy Cancer Institute	Villejuif
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Maastro Clinic	Maastricht
Netherlands	Erasmus Medical Centre	Rotterdam
Netherlands	University Medical Centre Utrecht	Utrecht
Spain	University Hospital Vall d'Hebron	Barcelona
Sweden	Karolinska Institute	Stockholm
United Kingdom	Christie Hospital NHS Trust	Manchester

Sponsors (8)

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

Countries where clinical trial is conducted

France,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	locoregional recurrence-free survival		2 years
Primary	number of patients with grade 3 toxicity or more		2 years
Secondary	Quality of Life assessment		2 years
Secondary	swallowing preservation	Tube feeding dependency at one year	1 year
Secondary	progression free survival		2 years
Secondary	overall survival		2 years