NCT01504815CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 29 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 268 (actual)
- First submitted
- 15 Dec 2011
- Start date
- 7 Sept 2012
- Primary completion date
- 1 Dec 2021
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Head and neck cancer
- NCT number
- NCT01504815
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 268
- From 7 Sept 2012 to the primary completion date, 1 Dec 2021
- 9 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- expected failure from follow-up
- previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- known active symptomatic fungal, bacterial and/or viral infections including HIV
Other
- expected inability to complete either one of the treatment arms
- pregnancy or lactation
- patients (m/f) with reproductive potential not implementing adequate contraceptive measures
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Gustave Roussy Cancer Institute Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Christie Hospital NHS Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Maastro Clinic Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Erasmus Medical Centre Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| University Medical Centre Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Karolinska Institute Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.