A phase II trial of radiotherapy-durvalumab without prophylactic neck irradiation in squamous cell carcinoma of the head and neck (REWRITe) - GORTEC 2018-02

Groupe Oncologie Radiotherapie Tete Cou0 sites61 target enrollmentJuly 10, 2024

Conditionsntreated squamous cell carcinoma of the head and neck MedDRA version: 26.1Level: PTClassification code: 10060121Term: Squamous cell carcinoma of head and neck Class: 100000004864 Therapeutic area: Diseases [C] - Neoplasms [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ntreated squamous cell carcinoma of the head and neck
Sponsor: Groupe Oncologie Radiotherapie Tete Cou
Enrollment: 61
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 10, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Groupe Oncologie Radiotherapie Tete Cou

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years with no upper limit, Performance Status ECOG 0\-2, Squamous cell carcinoma, previously untreated, T1\-T4 with clinical status N0\-N1, N2a or N2b non palpable, with only homolateral lymph node in radiological examinations., Patient with at least one of these fragility criteria : o Status ECOG 1 with multiple comorbidities, at least 2 pathologies with grade \= 2 (renal and/or cardiac and/or vascular and/or hepatic, and/or neurologic, and/or pulmonary) o Status ECOG \= 2 o Age \= 70 , judged unfit with oncogeriatric evaluation by EGE (ELAN Geriatric Evaluation) test or unable to receive cisplatine or Carboplatine\- 5FU (at least one criteria listed below\*) \* Criteria for determining if a patient is unfit for receiving cisplatine or carbo\-5FU : Calculated creatinine clearance \= 60 mL/min as determined by the modified. method of Cockcroft and Gault or glomerular filtration rate \= 60 mL/min/1\.73m² (CKD\-EPI method recommended) Haemoglobin \< 10 g/dL, aspartate (AST) and alanine transaminase (ALT) more than 2 times the upper limit of the normal range (ULN), serum albumin \=35 g/L, Absolute neutrophil count \= 1 500/µL, platelets \= 100 000/µL or total bilirubin \= 1\.5 mg/dL Cardiac function not compatible with hyperhydration or significant heart disease Weight loss \> 15% in 2 months, Oral cavity, oropharynx, hypopharynx or larynx, Documentation of p16 disease (HPV status for oropharyngeal tumor), Glomerular filtration rate (GFR) \>40 mL/min/1\.73m2 (CKD\-EPI method recommended) or Calculated creatinine clearance CL\>40 mL/min by the Cockcroft\- Gault formula

Exclusion Criteria

•Nasopharyngeal, paranasal sinuses, nasal cavity tumors or thyroid cancers, Metastatic disease, Any prior or current treatment for invasive head and neck cancer, 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, Body weight \= 30 kg and/or weight loss of \= 15% during the last 4 weeks (except if renutrition with a feeding tube is planned before the onset of treatment or is ongoing), Other severe acute or chronic medical conditions including pneumonitis, pulmonary fibrosis, Active autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]), Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent