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2024-514919-10-00Active, not recruitingPhase 4

Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemoradiation in sarcopenic head and neck cancer patients

Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemoradiation in sarcopenic patients with head and neck squamous cell carcinoma

Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Nov 2024

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Brief summary (registry, in English)

To investigate if the use of weekly low dose cisplatin increases compliance to the planned chemotherapy scheme in LA-HNSCC patients with low SMM to a level of compliance to three-weekly high dose cisplatin of patients without low SMM.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
160 (estimated)
First submitted
9 Oct 2024
Start date
24 Jan 2022
Lead sponsor
Universitair Medisch Centrum Utrecht
EU CT number
2024-514919-10-00
EudraCT number
2021-002634-16

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 160
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • mentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent; - a history of bilateral lymph node dissection in the neck and no available (PET-)CT scan of the third lumbar vertebra; - an absolute contraindication for cisplatin as defined by the treating physician, including relevant pre-existing kidney insufficiency, clinically apparent vascular disease (for example claudicatio intermittens), clinically relevant perceptive deafness, serious neuropathy and poor performance score;

Who the study is looking for

  • considered, eligible and planned for primary cisplatin CRT by treating physician; - eighteen years of age or older; - sufficient understanding of Dutch and medical consequences to give informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (5)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Noordwest Ziekenhuisgroep StichtingAlkmaarNetherlandsActive, not recruiting
Amsterdam UMC StichtingAmsterdamNetherlandsActive, not recruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdamNetherlandsActive, not recruiting
Leids Universitair Medisch Centrum (LUMC)LeidenNetherlandsActive, not recruiting
Universitair Medisch Centrum UtrechtUtrechtNetherlandsActive, not recruiting

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.