EORTC-2014-HNCG: PROLoNg: Pembrolizumab and Radiotherapy for OLigometastatic squamous cell carcinoma of the head and Neck: a randomized phase III study

Conditions

Squamous cell carcinoma of head and neck

Brief summary

Progression-free survival by RECIST 1.1, as assessed by the local investigator

Detailed description

Overall survival, Disease-specific survival, Time to disease progression, Time to development of new metastatic lesions, Time to progression in oligometastatic lesions initially present at enrolment, Adverse events according to CTCAE version 5.0, Patient reported tolerability: dyspnoea, pain, insomnia, fatigue, appetite loss, nausea, constipation, diarrhoea, anxiety, coughing, dry mouth, neurological problems, trismus, problems with senses, problems with shoulder, skin problems, swallowing, swelling in neck, problems with speech, problems with teeth and weight loss scales as measured by the QLQ-C15-PAL and EORTC IL243 questionnaires, Patient reported benefit: physical functioning and burden of illness scales as measured by the QLQ-C15-PAL and EORTC IL243

Related papers

No related papers found yet.

Interventions

DRUGPEMBROLIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival by RECIST 1.1, as assessed by the local investigator	—

Secondary

Measure	Time frame
Overall survival, Disease-specific survival, Time to disease progression, Time to development of new metastatic lesions, Time to progression in oligometastatic lesions initially present at enrolment, Adverse events according to CTCAE version 5.0, Patient reported tolerability: dyspnoea, pain, insomnia, fatigue, appetite loss, nausea, constipation, diarrhoea, anxiety, coughing, dry mouth, neurological problems, trismus, problems with senses, problems with shoulder, skin problems, swallowing, swelling in neck, problems with speech, problems with teeth and weight loss scales as measured by the QLQ-C15-PAL and EORTC IL243 questionnaires, Patient reported benefit: physical functioning and burden of illness scales as measured by the QLQ-C15-PAL and EORTC IL243	—

Measure

Time frame

Overall survival, Disease-specific survival, Time to disease progression, Time to development of new metastatic lesions, Time to progression in oligometastatic lesions initially present at enrolment, Adverse events according to CTCAE version 5.0, Patient reported tolerability: dyspnoea, pain, insomnia, fatigue, appetite loss, nausea, constipation, diarrhoea, anxiety, coughing, dry mouth, neurological problems, trismus, problems with senses, problems with shoulder, skin problems, swallowing, swelling in neck, problems with speech, problems with teeth and weight loss scales as measured by the QLQ-C15-PAL and EORTC IL243 questionnaires, Patient reported benefit: physical functioning and burden of illness scales as measured by the QLQ-C15-PAL and EORTC IL243

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Countries

Belgium, Italy, Spain

Outcome results

None listed