De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

Recruiting Phase 2 Phase 3 Interventional Study
Squamous Cell Carcinoma of the Oral Cavity Squamous Cell Carcinoma of the Larynx Squamous Cell Carcinoma of the Hypopharynx Squamous Cell Carcinoma of the Oropharynx
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
508 (estimated)
Sponsor
University of Erlangen-Nürnberg Medical School · Other
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About This Trial

This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0)) 2. Surgery of primary tumor and neck dissection performed according to predefined surgical standard 3. Indication for postoperative radio(chemo)therap…
Contacts

Marlen Haderlein, PD

+49913185

marlen.haderlein@uk-erlangen.de

CONTACT

Studiensekretariat

+49913185

studiensekretariat.ST@uk-erlangen.de

CONTACT