Trial | NCT01504815  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Intervention/Treatment

    cisplatin ...

  • Study Participants

    268
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 Started
Mar 31
2012
Primary Completion
Nov 30
2023
Anticipated
Study Completion
Sep 30
2025
Anticipated
Last Update
Jul 06
2023

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

Cisplatinum + conventional RT Active Comparator

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

Cisplatinum + adaptive high dose RT Experimental

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

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
No Results Posted