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Status:

COMPLETED

Adaptive Radiation Treatment for Head and Neck Cancer

Lead Sponsor:

The Netherlands Cancer Institute

Collaborating Sponsors:

Karolinska Institutet

Maastricht Radiation Oncology

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18-70 years

Phase:

PHASE3

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 prima...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 7 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 24 2024

Estimated Enrollment :

268 Patients enrolled

Trial Details

Trial ID

NCT01504815

Start Date

September 7 2012

End Date

December 24 2024

Last Update

January 29 2025

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

Gustave Roussy Cancer Institute

Villejuif, France, 94800

2

Netherlands Cancer Institute

Amsterdam, Netherlands, 1066CX

3

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

4

Maastro Clinic

Maastricht, Netherlands, NL-6229 ET