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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513977-31-00
Acronym
GORTEC 2018-02
Enrollment
61
Registered
2024-07-24
Start date
2019-07-17
Completion date
Unknown
Last updated
2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated squamous cell carcinoma of the head and neck

Brief summary

Regional (neck) nodal control rate at 1 year

Detailed description

Early and late adverse events of grade ≥ 2, according to the CTCAE V5.0, Local control at the primary site, Locoregional nodal + primary site control rate, Distant metastases control rate, Ultimate regional control including salvage surgery and/or salvage RT), Overall survival, Objective Response Rate, Progression-free survival, QLQ C30 and QLQ-H&N35 scores at baseline, 3, 12 and 24 months post RT

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Sponsors

Groupe Oncologie Radiotherapie Tete Cou
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Regional (neck) nodal control rate at 1 year—

Secondary

MeasureTime frame
Early and late adverse events of grade ≥ 2, according to the CTCAE V5.0, Local control at the primary site, Locoregional nodal + primary site control rate, Distant metastases control rate, Ultimate regional control including salvage surgery and/or salvage RT), Overall survival, Objective Response Rate, Progression-free survival, QLQ C30 and QLQ-H&N35 scores at baseline, 3, 12 and 24 months post RT—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026