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Adaptive Radiation Treatment for Head and Neck Cancer

NCT01504815 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2025-01-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

cisplatinum

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

RADIATION

Conventional radiotherapy

conventional radiotherapy, 70Gy in 7 weeks

RADIATION

Adaptive radiotherapy

adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Maastricht Radiation Oncology

    collaborator OTHER

  • Institut Catala de Salut

    collaborator OTHER_GOV

  • The Christie NHS Foundation Trust

    collaborator OTHER

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • European Union

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Olga Hamming-Vrieze, MD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-07
Primary Completion
2021-12-01
Completion
2024-12-24

Countries

  • France
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504815 on ClinicalTrials.gov