A phase II trial of radiotherapy-durvalumab without prophylactic neck irradiation in squamous cell carcinoma of the head and neck - REWRITe

GORTEC0 sites73 target enrollmentOctober 22, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ntreated Squamous cell carcinoma : Oral cavity, oropharynx, hypopharynx or larynx
Sponsor: GORTEC
Enrollment: 73
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

October 22, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Age \> 18 years with no upper limit
•2\.Performance Status ECOG 0\-2
•3\.Non\-eligible to existing SOC with chemo\-RT or cetuximab\-RT
•4\.Squamous cell carcinoma, previously untreated
•5\.T1\-T2 N0 with measurable disease for whom the risk of nodal spread is estimated to be low (\< 10\-15%) or T3\-T4 N0 with measurable disease for whom large field neck irradiation may not be appropriate due to age, and/or fragile condition (PS2\)
•6\.N0 neck based on clinical, MRI and FDG/PET\-CT examinations
•7\.Oral cavity, oropharynx, hypopharynx or larynx
•8\.Availability of pre\-treatment tumor tissue sample (for PD\-L1 expression, TILs and immune landscape)
•9\.Documentation of p16 disease (HPV status for oropharyngeal tumor)
•10\.Recording of alcohol consumption and smoking history

•1\.Nasopharyngeal, paranasal sinuses, nasal cavity tumors or thyroid cancers
•2\.Metastatic disease
•3\.Active CNS disease
•4\.Any prior or current treatment for invasive head and neck cancer
•5\.Any unresolved toxicity NCI CTCAE V5\.0 Grade \=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
•a. Patients with Grade \=2 neuropathy will be evaluated on a case\-by\-case basis
•b. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the investigator
•6\.Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
•7\.History of leptomeningeal carcinomatosis
•8\.Body weight \= 30 kg and/or weight loss of \= 15% during the last 4 weeks (except if re\-nutrition with a feeding tube is planned before the onset of treatment or is ongoing)