Dutch randomized multicenter trial COmparing twO PalliativE RAdiaTION schemes for incurable head and neck cancer (COOPERATION)

Phase 3

Completed

• Conditions: 10027655; Head and Neck Cancer

• Registration Number: NL-OMON44823
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

* Newly diagnosed patients with primary non-metastatic carcinoma located in the oral cavity, oropharynx, larynx (except T1 glottic), hypopharynx, nasopharynx, paranasal sinuses and salivary gland and carcinoma of unknown primary in the head and neck region who are not suitable for radical treatment with surgery or (chemo)radiotherapy and, therefore, planned for treatment with radiotherapy in palliative setting.
OR
* Newly diagnosed patients with primary head and neck carcinoma with limited metastatic disease in a good general condition with life expectancy of at least 6 months are also eligible.
* Age * 18 years
* WHO performance status 0 - 2
* Signed written informed consent

Exclusion Criteria

* Patients with previously radiation treatment in the head and neck region, for any reason with the exception of basal cell carcinoma of the skin
* Chemotherapy or surgery for head and neck tumor before inclusion and no other
concomitant anti*cancer therapy (in terms of chemotherapy, biological etc) is allowed during study treatment
* Patients with head and neck malignancies arising from skin, nose, thyroid gland or esophagus
* Patients with advanced stage sarcoma or lymphoma of the head and neck region
* Expected life expectancy of less than 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* loco-regional progression </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* overall survival rates<br /><br>* the impact of both radiation schemes on QoL<br /><br>* loco-regional control<br /><br>* overall response<br /><br>* compliance to both radiation schemes.<br /><br>* the incidence of grade * 2 acute and late toxicity </p><br>