Spots Global Cancer Trial Database for De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

Study Description

Brief Summary: 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.

Detailed Description: This study aims to determine whether it is possible to achieve an individual target volume concept that eliminates elective irradiation of uninvolved lymph drainage areas while maintaining clearly defined surgical standards and using modern imaging and radiation techniques. The aim of this study is to achieve reduced late toxicity without compromising locoregional control. Patients will be randomized to: either RT to primary tumor region, regions with lymph node metastases and elective nodal irradiation (control arm) or RT to primary tumor region and regions with lymph node metastases without elective nodal irradiation (investigational arm) A two-stage design was chosen for this purpose. Phase II: A randomized phase II study whose primary endpoint is the 1-year percutaneous endoscopic gastrostomy (PEG) tube dependence rate will be performed first. Phase III: If the primary endpoint of the phase II study is met and the interim analysis shows no increase in the locoregional recurrence rate in the study/investigational arm, the study will be continued as a phase III study whose primary endpoint is the locoregional control rate.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial